Wed Nov 27 2024
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Drug | Manufacturer | Distribution Pattern | Number of Affected Units |
---|---|---|---|
Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-129-01 | Safecor Health, LLC | USA nationwide. | 1470 boxes |
Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-106-01 | Safecor Health, LLC | USA nationwide. | 791 boxes |
Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01 | USA nationwide. | 587 boxes | |
Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01 | USA nationwide. | 3139 boxes | |
Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01 | USA nationwide. | 7488 boxes |