Recalls / Class II
Class IID-0532-2020
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
- Brand name
- Hydrocodone Bitartrate And Homatropine Methylbromide
- Generic name
- Hydrocodone Bitartrate And Homatropine Methylbromide Oral Solution
- Active ingredients
- Homatropine Methylbromide, Hydrocodone Bitartrate
- Route
- Oral
- NDC
- 10702-150
- FDA application
- ANDA207487
- Affected lot / code info
- Lot #: 14375A, Exp. date 2019-DEC; 14398A, Exp. date 2020-JAN
Why it was recalled
Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
Recalling firm
- Firm
- KVK-Tech, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 110 Terry Dr, N/A, Newtown, Pennsylvania 18940-3427
Distribution
- Quantity
- 1534 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-11-01
- FDA classified
- 2019-11-29
- Posted by FDA
- 2019-11-20
- Terminated
- 2020-04-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0532-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.