Drug 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
D-0814-2021
Product summary
- Event
- Event 88629
- Status
- Completed
- Classification
- Class II
- Quantity
- 116,400 bottles
- Official record key
drug-enforcement:D-0814-2021
Official wording
Reason: CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Code information: Lot #: UV1335; UV1352; and UV1373
Distribution pattern: Nationwide USA and China
Derived failure modes
-
Manufacturing or process control
CGMP Deviations