Benzhydrocodone and Acetaminophen Tablets — Class III drug recall D-0224-2021
Terminated recall by KVK-Tech, Inc., reported 2021-01-20, distributed nationwide. Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity durin
| Recall number | D-0224-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | KVK-Tech, Inc., Newtown, PA, United States |
| Recall initiated | 2020-12-18 |
| Classified | 2021-01-11 |
| Reported by FDA | 2021-01-20 |
| Terminated | 2021-03-19 |
| Distributed | Nationwide (US) |
| Quantity | 528 bottles |
| Reason classes | specification failure |
| NDC | 10702-0344-01 |
| Lot numbers | 15892A, 2021-FEB |
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
Reason for recall
Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0224-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.