Home / Recalls / AuroMedics Pharma LLC / D-0526-2020

D-0526-2020 Class II Ongoing

Recalled by AuroMedics Pharma LLC — East Windsor, NJ

FDA drug recall D-0526-2020 was initiated by AuroMedics Pharma LLC on November 6, 2019 and is designated Class II. Reason for recall: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups. The recall status is ongoing. Affected quantity: 69,696 bottles.

Recall Details

Product Type
Drugs
Report Date
December 4, 2019
Initiation Date
November 6, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
69,696 bottles

Product Description

DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79

Reason for Recall

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

Distribution Pattern

nationwide

Code Information

Lot # NBSB19001DA3; Exp FEB 2021

Other recalls by AuroMedics Pharma LLC

  • D-0020-2023 Class II — Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Sy (September 30, 2022)
  • D-1551-2022 Class III — Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose v (September 26, 2022)
  • D-0013-2023 Class II — Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx onl (September 26, 2022)
  • D-0556-2022 Class I — Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in (January 26, 2022)
  • D-0248-2021 Class II — Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, (December 30, 2020)
  • D-0853-2020 Class III — Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vi (February 7, 2020)
  • D-0852-2020 Class II — Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bott (February 7, 2020)
  • D-0789-2020 Class III — Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For To (December 2, 2019)
  • D-0574-2020 Class II — Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count (November 25, 2019)
  • D-0636-2020 Class I — Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Au (November 20, 2019)

FDA data resources