FDA Drug recall D-0386-2021
Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd
- FDA Drug
- Class III
- terminated
- Published 2021-05-26
On 2021-05-26 the FDA classified a Class III recall of Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd by Kvk Tech, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0386-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-04-27 |
| Published | 2021-05-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Kvk Tech |
| Distribution | US |
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
Failed Impurities/Degradation Specifications
Identifiers
| ndc | 10702-055-03 |
|---|---|
| ndc | 10702-055-09 |
| ndc | 10702-055-01 |
| ndc | 10702-055-10 |
| code_info | Lot: 15684A, Exp 7/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Kvk Tech
- Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd
FDA Drug · Class II · 2025-05-28 · Kvk Tech - Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd
FDA Drug · Class II · 2025-05-28 · Kvk Tech - Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC# 10702-013-01
FDA Drug · Class I · 2023-10-25 · Kvk Tech - Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd
FDA Drug · Class I · 2021-09-01 · Kvk Tech - Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., Newtown, PA 18940 US…
FDA Drug · Class III · 2021-01-20 · Kvk Tech
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0386-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.