Sirolimus Tablets Recalled for Failed Impurities and Degradation Specifications
American Health Packaging is recalling Sirolimus 1 mg tablets (Lot #1000789, expiring 10/31/2022) distributed nationwide because they failed impurities and degradation specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The hazard is a quality/specification failure without evidence of actual harm. Per the rubric, Class III recalls are typically scored 1–2; the moderate score reflects the nature of the defect affecting a critical immunosuppressant drug, though no patient harm has been reported.
Plain-English summary
American Health Packaging is recalling 290 cartons of Sirolimus 1 mg tablets (Lot #1000789, expiration date 10/31/2022) distributed nationwide in the United States. The product failed to meet FDA specifications for impurities and degradation.
Sirolimus is a prescription oral immunosuppressant drug used in patients who have received organ transplants. The failure to meet impurities and degradation specifications means the drug's quality, purity, or potency may not be assured.
Patients taking this medication should contact their healthcare provider or pharmacy to determine if their supply is affected. Patients should not stop taking their medication without consulting their healthcare provider. Healthcare providers and patients should check the lot number and expiration date on their medication to identify if it is part of this recall.
The recalled product
- Product
- SIROLIMUS (SIROLIMUS)
- Brand
- SIROLIMUS
- Manufacturer
- American Health Packaging
- Hazard
- impurities
- degradation
- quality-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 1000789
- Exp. Date 10/31/2022
Distribution
Distributed nationwide across the United States.
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