Recall Enforment Report D-0057-2025

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Safecor Health, LLC, originally initiated on 11-11-2024 for the product Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01 The product was recalled due to cgmp deviations: observations were made that some blister card-foils were separating from the blister cavity.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0057-202511-11-202411-27-2024Class II3139 boxesVitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.Ongoing
D-0056-202511-11-202411-27-2024Class II7488 boxesVitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.Ongoing
D-0060-202511-11-202411-27-2024Class II587 boxesDocusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.Ongoing
D-0058-202511-11-202411-27-2024Class II1470 boxesAspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-129-01cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.Ongoing
D-0059-202511-11-202411-27-2024Class II791 boxesCalcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-106-01cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
48433-106Calcium Antacid Calcium CarbonateTablet, ChewableOralSafecor Health, LlcHuman Otc Drug
48433-129Aspirin ChewableAspirin 81 MgTabletOralSafecor Health, LlcHuman Otc Drug