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

FDA recall notice · announced March 20, 2019 · Avkare

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Reason for recall

Failed Dissolution Specifications

Notes

Distribution: Nationwide.
Lot/code information: Lots: a) 22738 Exp. 07/2020 and b) 22739 Exp. 07/2020
Quantity: a) 2947 and b) 3379
Status: Terminated
Products in this recall event:
- 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 (D-0990-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.