AVKARE Inc. recalls Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC 42291…
- Recall date
- March 1, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0990-2019
- FDA classification
- Class III
- Brand / firm
- AVKARE Inc.
- Sold / distributed
- Nationwide.
Why it was recalled
Failed Dissolution Specifications
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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