Dr. Reddy's Recalls Sirolimus Tablets Due to Impurity
Dr. Reddy's Laboratories is recalling specific lots of Sirolimus tablets because they failed impurity specifications for secorapamycin.
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: The FDA classified this as a Class III recall, which is typically associated with minor labeling errors or low-risk contamination where adverse health consequences are unlikely.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling 9,330 bottles of Sirolimus Tablets, 1 mg, 100-count. The recall involves specific lots with expiration dates ranging from July 2016 to November 2016. The product is distributed nationwide.
The recall was initiated because the product failed impurity/degradation specifications, specifically regarding the impurity secorapamycin. The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
Patients who have been prescribed this medication should consult their healthcare provider for guidance on alternative treatments or further instructions. Consumers should not attempt to return the medication to the pharmacy without consulting their prescriber first.
The recalled product
- Product
- SIROLIMUS (SIROLIMUS)
- Brand
- SIROLIMUS
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 9,330
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 (11)
- Lot # H400044
- H400045
- Exp 07/16
- H400048
- Exp 08/16
- H400055
- Exp 10/16
- H400070
- H400071
- H400073 and H400074
- Exp 11/16
UPCs (1)
- 0355111654018
Distribution
Distributed nationwide across the United States.
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