Drug 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
D-0532-2020
Product summary
- Firm
- KVK-Tech, Inc.
- Event
- Event 84184
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1534 bottles
- Official record key
drug-enforcement:D-0532-2020
Official wording
Reason: Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
Code information: Lot #: 14375A, Exp. date 2019-DEC; 14398A, Exp. date 2020-JAN
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance