Drug product
Dicyclomine Hydrochloride Tablets, USP 20 mg, 100 Tablets, Rx only, Manufactured For: Teva Pharmaceuticals USA, Parsippany, NJ 07054. NDC: 0591-0795-01
D-0175-2024
Product summary
- Event
- Event 89450
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
drug-enforcement:D-0175-2024
Official wording
Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Code information: Batch 3197790
Distribution pattern: Nationwide USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations