Home / Months / August 2023

FDA Warning Letters, 483s and Recalls: August 2023

FDA enforcement records dated August 2023: 50 warning letters outside tobacco (plus 31 tobacco letters), 47 OAI inspections and 105 Class I recalls. FDA publishes some records weeks after their date, so recent months can still grow.

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Warning letters

A warning letter is FDA's formal notice that a firm has significant violations. Company names link to the letter on fda.gov. Tobacco retailer letters are counted above but not listed.

DateCompanyIssuing officeSubject
Aug 31, 2023Caltag Medsystems LtdCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Aug 30, 2023ByHeart, Inc.HUMAN AND ANIMAL FOOD WEST I COMPLIANCE BRANCH (HAFW1-CB)CGMP/Quality Control/Adulterated/Infant Formula
Aug 30, 2023Perrigo Wisconsin, LLCHUMAN AND ANIMAL FOOD WEST I COMPLIANCE BRANCH (HAFW1-CB)CGMP/Quality Control/Adulterated/Infant Formula
Aug 30, 2023Reckitt/Mead Johnson NutritionHUMAN AND ANIMAL FOOD WEST I COMPLIANCE BRANCH (HAFW1-CB)CGMP/Quality Control/Adulterated/Infant Formula
Aug 28, 2023Gilster-Mary Lee CorporationDivision of Human and Animal Food Operations East VIFood Labeling/Misbranded
Aug 28, 2023MKK ImportsDivision of West Coast ImportsForeign Supplier Verification Program (FSVP)
Aug 25, 2023Neitz Instruments Company Ltd.Center for Devices and Radiological HealthMedical Device Reporting/Misbranded
Aug 24, 2023Tijuana’S Produce Inc.Division of West Coast ImportsForeign Supplier Verification Program (FSVP)
Aug 23, 2023Green Pharmaceutical Co. Ltd.Center for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Aug 23, 2023Osmosis, LLCDivision of Human and Animal Food Operations East IVUnapproved New Drugs/Misbranded
Aug 21, 2023Suther Feeds, Inc.Division of Human and Animal Food Operations West IICGMP/Medicated Feeds/Adulterated
Aug 18, 2023Amazon.Com, IncCenter for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded
Aug 18, 2023Molluscumaway LLCCenter for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded
Aug 18, 2023MolluscumRx, Inc.Center for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded
Aug 18, 2023Nature’S Innovation, Inc.Center for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded
Aug 18, 2023Thrasio, LLC D/B/A ZymaDermCenter for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded
Aug 18, 2023Walmart, IncCenter for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded
Aug 17, 2023Lex Inc.Division of Pharmaceutical Quality Operations IICGMP/Finished Pharmaceuticals/Adulterated
Aug 16, 2023Essential Research, LLCCenter for Veterinary MedicineUnapproved New Animal Drug Products
Aug 16, 2023King Systems Corp. Dba Ambu, Inc.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded
Aug 15, 2023FVD Produce, LLCDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)
Aug 15, 2023Gadal Laboratories Inc.Division of Pharmaceutical Quality Operations IICGMP/Finished Pharmaceuticals/Adulterated
Aug 14, 2023Battle Creek Co-Op/CHS, LLC Dba Progressive NutritionDivision of Human and Animal Food Operations West IICGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated
Aug 14, 2023K. Boeun Pharmaceutical Co., Ltd.Center for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Aug 11, 2023Cosmobeauti Laboratories & Manufacturing Inc.Center for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Aug 10, 2023Tesla BioHealing, Inc.Division of Medical Device and Radiological Health Operations EastMedical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
Aug 9, 2023ALVA-AMCO Pharmacal Companies, LLCOffice of Unapproved Drugs and Labeling ComplianceUnapproved New Drugs/Misbranded
Aug 9, 2023CalmCo LLC Previously Named Ketomi LLCCenter for Drug Evaluation and Research | CDERUnapproved New Drugs/Misbranded
Aug 8, 2023Angela M. Stupi, M.D.Center for Drug Evaluation and Research | CDERClinical Investigator
Aug 8, 2023International Laboratories Corp. Ltd.Center for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Aug 8, 2023Source-Omega LLCDivision of Human and Animal Food Operations East VNew Drug/Misbranded
Aug 7, 2023Ikal LLCDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)
Aug 7, 2023Laavo Clean, S.A. De C.V.Center for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Aug 4, 2023AstraZeneca Pharmaceuticals LPThe Office of Prescription Drug Promotion (OPDP)False & Misleading Claims/Misbranded
Aug 4, 2023Biorica International Corp.Center for Food Safety and Applied Nutrition (CFSAN)New Drug/Misbranded
Aug 4, 2023Cergomex Imports, LLCCenter for Drug Evaluation and Research | CDERRefusal to Provide Access to and Copying of Records
Aug 4, 2023Day Light NutritionDivision of Human and Animal Food Operations West IINew Drug/Misbranded
Aug 4, 2023GTP International CorpCenter for Drug Evaluation and Research | CDERRefusal to Provide Access to and Copying of Records
Aug 3, 2023Avaria Health & Beauty Corp.Center for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Aug 3, 2023Daxal Cosmetics Private LimitedCenter for Drug Evaluation and Research | CDERRefusal to Provide Access to and Copying of Records
Aug 3, 2023Fancystage Unipessoal, LDACenter for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Aug 3, 2023K.C. Pharmaceuticals Inc.Division of Pharmaceutical Quality Operations IVCGMP/Finished Pharmaceuticals/Adulterated
Aug 3, 2023KM Pharmaceutical Co. Ltd.Center for Drug Evaluation and Research | CDERRefusal to Provide Access to and Copying of Records
Aug 3, 2023LCC Ltd.Center for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Aug 3, 2023Orchid LifesciencesCenter for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Aug 3, 2023Sangleaf Pharm., Co. Ltd.Center for Drug Evaluation and Research | CDERFailure to Provide Information
Aug 3, 2023Skyline Herbals Private LimitedCenter for Drug Evaluation and Research | CDERRefusal to Provide Access to and Copying of Records
Aug 3, 2023Suhan AerosolCenter for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Aug 3, 2023Tan Alize Kozmetik Ve Temizlik UrunleriCenter for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Aug 1, 2023Moorish Science Temple, The Divine And National Movement Of North America, Inc; #13 The Moorish American National Republic Dba Moor Herbs, Inc.Division of Human and Animal Food Operations East VIUnapproved New Drugs/Misbranded

OAI inspections

OAI (Official Action Indicated) means FDA recommends regulatory and/or administrative action after the inspection. Facility names link to the facility's FDA record.

DateFacilityProduct typeCountry
Aug 31, 2023Biomic Sciences, LLCFood/CosmeticsUnited States
Aug 31, 2023Mexpobaja CorporationFood/CosmeticsUnited States
Aug 31, 2023O3UV, LLCDevicesUnited States
Aug 31, 2023Sheng Kee Of California, IncFood/CosmeticsUnited States
Aug 29, 2023Boothwyn Pharmacy LLCDrugsUnited States
Aug 28, 2023Furst-McNess CompanyVeterinaryUnited States
Aug 25, 2023Central Admixture Pharmacy Services IncDrugsUnited States
Aug 25, 2023Korean Food Inc.Food/CosmeticsUnited States
Aug 25, 2023Miguelangelo J. Perez-Cruet, M.D., M.S.DevicesUnited States
Aug 24, 2023Aman Kapoor IncFood/CosmeticsUnited States
Aug 24, 2023Dairy Feeds IncVeterinaryUnited States
Aug 24, 2023SINO MEDICAL SCIENCES TECHNOLOGY INC.DevicesChina
Aug 23, 2023Pt Dua KelinciFood/CosmeticsIndonesia
Aug 23, 2023Zoet Poultry Inc.Food/CosmeticsUnited States
Aug 21, 2023Innovative Textiles, Inc.Food/CosmeticsUnited States
Aug 18, 2023Les Importations Herbasante Inc.VeterinaryCanada
Aug 17, 2023Angela D. Ritter, M.D.DrugsUnited States
Aug 17, 2023KYAW KHIN, INCFood/CosmeticsUnited States
Aug 16, 2023InfuTronix LLCDevicesUnited States
Aug 16, 2023Pure Simple Products Aka Northern ElderberryFood/CosmeticsUnited States
Aug 16, 2023Zyno Medical LLCDevicesUnited States
Aug 15, 2023AMMAN PHARMACEUTICAL INDUSTRIESDrugsJordan
Aug 15, 2023F1 Foods IncFood/CosmeticsUnited States
Aug 15, 2023U S Gulf Coast Trading Company, IncFood/CosmeticsUnited States
Aug 14, 2023Astellas Pharma US Inc.DrugsUnited States
Aug 14, 2023Banjaras IncFood/CosmeticsUnited States
Aug 11, 2023Indrayani Hospital And Cancer InstituteDrugsIndia
Aug 11, 2023LA ALDEA DISTRIBUTORS INCFood/CosmeticsUnited States
Aug 10, 2023Control-X Medical Zrt.DevicesHungary
Aug 10, 2023JJR GLOBAL INC.Food/CosmeticsUnited States
Aug 9, 2023Cavevi Naturals LLCFood/CosmeticsUnited States
Aug 9, 2023Mountain Oak Vapors LLCTobaccoUnited States
Aug 8, 2023ARYZ Trading LLCFood/CosmeticsUnited States
Aug 7, 2023SOHGAVE LLCFood/CosmeticsUnited States
Aug 4, 2023Hi-Pro Feeds LLCVeterinaryUnited States
Aug 4, 2023Mark A. Stein, Ph.D.DrugsUnited States
Aug 4, 2023Prime Lab LLCDrugsUnited States
Aug 4, 2023Sri Krishna Pharmaceuticals Limited - Unit IVVeterinaryIndia
Aug 4, 2023Thai Nakorn Patana Co., Ltd,DrugsThailand
Aug 3, 2023Inopak LtdDrugsUnited States
Aug 3, 2023Lohxa LLCDrugsUnited States
Aug 3, 2023Zhuhai United Laboratories Co. Ltd.DrugsChina
Aug 2, 2023Dream Wholesale IncFood/CosmeticsUnited States
Aug 2, 2023Fresenius Medical Care Renal Therapies Group, LLCDevicesUnited States
Aug 2, 2023Sovereign Pharmaceuticals, LLCDrugsUnited States
Aug 1, 2023KGR Distribution Corp.Food/CosmeticsUnited States
Aug 1, 2023Swabplus, L.P.DrugsUnited States

Most-cited Form 483 sections

The CFR sections FDA investigators cited most often in inspections that ended this month.

CFR sectionObservationCitations
21 CFR 1.502(a)Develop FSVP81
21 CFR 1.505(a)(2)Evaluation - performance, risk33
21 CFR 1.506(a)(1)Unapproved supplier procedures - importer established31
21 CFR 820.100(a)Lack of or inadequate procedures28
21 CFR 117.35(a)Sanitary operations - Plant sanitation27
21 CFR 1.506(d)(1)(i)Verification activity frequency23
21 CFR 117.130(a)(1)Hazard analysis - Identification of hazard21
21 CFR 111.70(e)Specifications - identity, purity, strength, composition19
21 CFR 117.80(c)Manufacturing, processing, packing, holding - Controls19
21 CFR 820.198(a)Lack of or inadequate complaint procedures19

Class I recalls

Class I is FDA's most serious recall class: a reasonable chance the product causes serious health problems or death.

DateFirmProduct typeReason
Aug 30, 2023Weis Markets, Inc., Ice Cream DivisionFoodUndeclared egg
Aug 26, 2023Dr. Berne's Whole Health ProductsDrugsNon-Sterility
Aug 25, 2023Hua Da Trading, Inc. Dba Wefun Inc.DrugsMarketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil, an ingredient found in a FDA approved…
Aug 25, 2023Marlex Pharmaceuticals, Inc.DrugsLabeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin…
Aug 25, 2023Philips Respironics, Inc.DevicesPower Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.
Aug 25, 2023Todorganic Inc.FoodProduct appears to be Yellow Oleander instead of Nuez de la India as labeled.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 22, 2023ICE CREAM HOUSEFoodProducts may be contaminated with Listeria monocytogenes.
Aug 21, 2023TEXAS TAMALE COMPANYFoodContains undeclared milk.
Aug 14, 2023Stonewall Kitchen, LLCFoodProduct may contain undeclared peanut, soy, and wheat.
Aug 10, 2023ARROW INTERNATIONAL Inc.DevicesThis recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected…
Aug 10, 2023ARROW INTERNATIONAL Inc.DevicesThis recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected…
Aug 10, 2023ARROW INTERNATIONAL Inc.DevicesThis recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected…
Aug 10, 2023ARROW INTERNATIONAL Inc.DevicesThis recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected…
Aug 8, 2023David Oppenheimer & Company I LLCFoodListeria monocytogenes
Aug 8, 2023David Oppenheimer & Company I LLCFoodListeria monocytogenes
Aug 8, 2023Fresenius Medical Care Holdings, Inc.DevicesThere is a potential for blood backfill leakage and foreign material.
Aug 8, 2023Fresenius Medical Care Holdings, Inc.DevicesThere is a potential for blood backfill leakage and foreign material.
Aug 8, 2023Fresenius Medical Care Holdings, Inc.DevicesThere is a potential for blood backfill leakage and foreign material.
Aug 8, 2023Mallinckrodt Manufacturing LLCDevicesThe One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.
Aug 8, 2023Real Kosher Ice Cream, Inc.FoodProduct may be contaminated with Listeria monocytogenes.
Aug 8, 2023Real Kosher Ice Cream, Inc.FoodProduct may be contaminated with Listeria monocytogenes.

Showing the latest 100 of 105.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.