FDAClass IIJune 10, 2015

Mycophenolic Acid Delayed-release Tablets recall: Failed Dissolution

Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC…

Why was Mycophenolic Acid Delayed-release Tablets recalled?

Failed Dissolution Specifications: Low out of specification dissolution results.

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?

Lot #: 3059043, Exp 08/16

Product
Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC…
Recalling firm
Mylan Lab Inc
Quantity
7,722 bottles
Distribution
Nationwide
Recall date
June 10, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls