Class II
Completed
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
This recall has been completed (originally issued September 29, 2021).
- Recall Initiated
- September 3, 2021
- Posted
- September 29, 2021
- Recall Number
- D-0815-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 14,904 bottles
- Firm Location
- Morton Grove, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Distribution
Nationwide USA and China
Lot / Code Info
Lot #: UV1198
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