FDAClass IIISeptember 29, 2021

Sirolimus Tablets 1 mg recall: Impurity Out of Spec

Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Health Packaging Columbus, OH 43217, NDC 68084-915-25

Why was Sirolimus Tablets 1 mg recalled?

Failed Impurities/Degradation 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?

Lot #: 1000789, Exp. Date 10/31/2022

Product
Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Health Packaging Columbus, OH 43217, NDC 68084-915-25
Recalling firm
American Health Packaging
Quantity
290 cartons
Distribution
Nationwide within the USA
Recall date
September 29, 2021
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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