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
Reason for recall: CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Recall initiated: 20210903
Status: Completed
Classification: Class II
Recall type: Voluntary: Firm initiated