Recall: D-0990-2019

Class III - Minor Violations

Class IIIClassification

2019-03-01Initiated

TerminatedStatus

AVKARE Inc.Firm

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

Failed Dissolution Specifications

Distribution

Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.