Recall: D-0813-2021

Class III - Minor Violations

Class IIIClassification

2021-05-12Initiated

TerminatedStatus

American Health PackagingFirm

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

Reason

Failed Impurities/Degradation Specifications

Distribution

Nationwide within the USA

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