FDAClass IISeptember 27, 2023

Rasagiline Tablets 0.5mg recall: Failed Dissolution

Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93

Why was Rasagiline Tablets 0.5mg recalled?

Failed dissolution specifications - results obtained were below spec average.

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 #: 3112444, Exp 8/2023

Product
Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93
Recalling firm
Aurobindo Pharma USA Inc.
Quantity
9,890 bottles
Distribution
USA nationwide
Recall date
September 27, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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