Drug product
Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., Newtown, PA 18940 USA, NDC 10702-344-01
D-0224-2021
Product summary
- Firm
- KVK-Tech, Inc.
- Event
- Event 87020
- Status
- Terminated
- Classification
- Class III
- Quantity
- 528 bottles
- Official record key
drug-enforcement:D-0224-2021
Official wording
Reason: Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A
Code information: Batch# 15892A, Exp, 2021-FEB
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification