Drug product
Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-Tech, Inc., Newtown, PA, 18940 NDC 10702-055-03
D-0386-2021
Product summary
- Firm
- KVK-Tech, Inc.
- Event
- Event 87810
- Status
- Terminated
- Classification
- Class III
- Quantity
- 17,096 bottles
- Official record key
drug-enforcement:D-0386-2021
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot: 15684A, Exp 7/2021
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications