Drug product
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup Net: 1 Pint (473 mL) Bulk Container-Not for Household Use Rx Only NDC 60432-275-16 Distributed By: Wockhardt USA, LLC Parsippany, NJ 07054
D-0596-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 bottles
- Official record key
drug-enforcement:D-0596-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: UV1092
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations