Recalls / Class III
Class IIID-0224-2021
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
- Affected lot / code info
- Batch# 15892A, Exp, 2021-FEB
Why it was recalled
Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A
Recalling firm
- Firm
- KVK-Tech, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 110 Terry Dr, N/A, Newtown, Pennsylvania 18940-3427
Distribution
- Quantity
- 528 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2020-12-18
- FDA classified
- 2021-01-11
- Posted by FDA
- 2021-01-20
- Terminated
- 2021-03-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0224-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.