Recalls / Class III
Class IIID-0990-2019
Product
Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC 42291-634-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478
- Brand name
- Oxybutynin Chloride
- Generic name
- Oxybutynin Chloride
- Active ingredient
- Oxybutynin Chloride
- Route
- Oral
- NDCs
- 42291-633, 42291-634, 42291-635
- FDA application
- ANDA078503
- Affected lot / code info
- Lots: a) 22738 Exp. 07/2020 and b) 22739 Exp. 07/2020
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- AVKARE Inc.
- Manufacturer
- AvKARE
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, N/A, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- a) 2947 and b) 3379
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2019-03-01
- FDA classified
- 2019-03-11
- Posted by FDA
- 2019-03-20
- Terminated
- 2020-01-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0990-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.