Recall Enforment Report D-0815-2021

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 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 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 Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0815-202109-03-202109-29-2021Class II14,904 bottlesPromethazine 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: 60432-606-16CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.Ongoing
D-0816-202109-03-202109-29-2021Class II38,748 bottlesValproic 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: 60432-621-16CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.Ongoing
D-0814-202109-03-202109-29-2021Class II116,400 bottlesPromethazine 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: 60432-608-16CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
60432-606Promethazine With Codeine Promethazine Hydrochloride And Codeine PhosphateSolutionOralMorton Grove Pharmaceuticals, Inc.Human Prescription Drug
60432-608Promethazine Hydrochloride Promethazine HydrochlorideSyrupOralMorton Grove Pharmaceuticals, Inc.Human Prescription Drug
60432-621Valproic Acid Valproic AcidSolutionOralMorton Grove Pharmaceuticals, Inc.Human Prescription Drug