Hydrocodone Bitartrate and Homatropine Methlybromide tablets — Class III drug recall D-0386-2021
Terminated recall by KVK-Tech, Inc., reported 2021-05-26, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-0386-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | KVK-Tech, Inc., Newtown, PA, United States |
| Recall initiated | 2021-04-27 |
| Classified | 2021-05-17 |
| Reported by FDA | 2021-05-26 |
| Terminated | 2022-10-05 |
| Distributed | Nationwide (US) |
| Quantity | 17,096 bottles |
| Reason classes | specification failure |
| NDC | 10702-0055, 10702-0055-01, 10702-0055-03, 10702-0055-09, 10702-0055-10 |
| Lot numbers | 15684A |
| Expiration dates | 2021-07 |
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
Reason for recall
Failed Impurities/Degradation Specifications
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-0386-2021. 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.