Safecor Health, LLC

FDA Regulatory Profile

Summary

Total Recalls
22
510(k) Clearances
0
Inspections
15
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0214-2026Class IIHaloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For IntramuscOctober 10, 2025
D-0251-2025Class IISimethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: SafeFebruary 17, 2025
D-0254-2025Class IIMorphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: HFebruary 17, 2025
D-0252-2025Class IIFerrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: AkFebruary 17, 2025
D-0250-2025Class IIErgocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 February 17, 2025
D-0253-2025Class IILorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, RefrigerateFebruary 17, 2025
D-0056-2025Class IIVitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, November 11, 2024
D-0057-2025Class IIVitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com,November 11, 2024
D-0060-2025Class IIDocusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.November 11, 2024
D-0058-2025Class IIAspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhNovember 11, 2024
D-0059-2025Class IICalcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safeNovember 11, 2024
D-0082-2024Class IIStrong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX October 19, 2023
F-0606-2017Class IIISafecor Vitamin B-1 (THIAMINE) 100 mg tablets NDC: 48433-0108-01 Distributed by: SAFECOR HEALTH, 3September 12, 2016
D-0904-2017Class IIDoxycycline100mg Tablets, 14-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801July 7, 2016
D-0900-2017Class IIAcetaminophen 325mg tablets, 120-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 009041982July 7, 2016
D-0903-2017Class IIAcyclovir 400mg Tablet, 15-count bottles, Rx only, Packaged by Safecor Health, LLC. Woburn, MA 01801July 7, 2016
D-0905-2017Class IIMetronidazole 500mg Tablet, 50-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01July 7, 2016
D-0901-2017Class IIAtorvastatin Calcium 40mg Tablet, 30-count bottles, Rx only, Pk By Safecor Health Woburn, MA 01801, July 7, 2016
D-0902-2017Class IICalcium Carbonate 600mg/Vitamin D3 400 International Units tablets, 60-count bottles, Pk By SafecorJuly 7, 2016
D-0657-2016Class IIMidazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf boxes, one shelf box contaAugust 13, 2015