Recalls / Class III
Class IIID-0386-2021
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
- Brand name
- Hydrocodone Bitartrate And Homatropine Methylbromide
- Generic name
- Hydrocodone Bitartrate And Homatropine Methylbromide
- Active ingredients
- Homatropine Methylbromide, Hydrocodone Bitartrate
- Route
- Oral
- NDC
- 10702-055
- FDA application
- ANDA207176
- Affected lot / code info
- Lot: 15684A, Exp 7/2021
Why it was recalled
Failed Impurities/Degradation Specifications
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
- 17,096 bottles
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2021-04-27
- FDA classified
- 2021-05-17
- Posted by FDA
- 2021-05-26
- Terminated
- 2022-10-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0386-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.