Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5… — Class II drug recall D-0532-2020
Terminated recall by KVK-Tech, Inc., reported 2019-11-20, distributed nationwide. Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
| Recall number | D-0532-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | KVK-Tech, Inc., Newtown, PA, United States |
| Recall initiated | 2019-11-01 |
| Classified | 2019-11-29 |
| Reported by FDA | 2019-11-20 |
| Terminated | 2020-04-16 |
| Distributed | Nationwide (US) |
| Quantity | 1,534 bottles |
| NDC | 10702-0150, 10702-0150-16 |
| Lot numbers | 14375A, 14398A, 2019-DEC, 2020-JAN |
Product
Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL bottles, Rx only, Mfd. by: KVK-Tech, Inc. Newtown PA 18940; NDC 10702-150-16
Reason for recall
Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
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-0532-2020. 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.