FDAClass IIIMarch 20, 2019

Oxybutynin Chloride Extended-Release Tablets USP 10 mg recall: Failed Dissolution

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…

Why was Oxybutynin Chloride Extended-Release Tablets USP 10 mg recalled?

Failed Dissolution Specifications

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lots: a) 22738 Exp. 07/2020 and b) 22739 Exp. 07/2020

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…
Recalling firm
AVKARE Inc.
Quantity
a) 2947 and b) 3379
Distribution
Nationwide.
Recall date
March 20, 2019
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls