Recall Enforment Report D-0814-2021
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Morton Grove Pharmaceuticals, Inc., originally initiated on 09-03-2021 for the product Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-608-16 The product was recalled due to cgmp deviations: potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.. 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-0814-2021 | 09-03-2021 | 09-29-2021 | Class II | 116,400 bottles | Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-608-16 | CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms. | Ongoing |
D-0815-2021 | 09-03-2021 | 09-29-2021 | Class II | 14,904 bottles | Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-606-16 | CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms. | Ongoing |
D-0816-2021 | 09-03-2021 | 09-29-2021 | Class II | 38,748 bottles | Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-621-16 | CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms. | Ongoing |