FDA Drug recall D-0532-2020
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
- FDA Drug
- Class II
- terminated
- Published 2019-11-20
On 2019-11-20 the FDA classified a Class II recall of 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 by Kvk Tech, citing presence of Foreign Substance: Black particles were found in the lots during retain sample inspection.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0532-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-01 |
| Published | 2019-11-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Kvk Tech |
| Distribution | US |
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
Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
Identifiers
| ndc | 10702-150-16 |
|---|---|
| code_info | Lot #: 14375A, Exp. date 2019-DEC; 14398A, Exp. date 2020-JAN |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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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 - Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd
FDA Drug · Class III · 2021-05-26 · Kvk Tech
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0532-2020%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.