Torrent Pharma Recalls Anagrelide Capsules Due to Impurity Failures
Torrent Pharma Inc. is recalling 2,472 bottles of Anagrelide Capsules because routine stability testing detected high levels of impurities.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 recall is classified as FDA Class II, which is typically associated with a temporary or medically reversible adverse health consequence. The source text does not report any specific illnesses, injuries, or fatalities, and the hazard is related to impurity levels detected during testing rather than a confirmed acute toxic event.
Plain-English summary
Torrent Pharma Inc. is recalling 2,472 bottles of Anagrelide Capsules, USP, 0.5 mg, 100-count. The product is a prescription-only medication manufactured in India for distribution in the United States and Puerto Rico. The specific lot affected is BFE2E003, with an expiration date of 08/31/2020.
The recall was initiated because routine stability testing revealed high out-of-specification results for impurities. This indicates that the product failed to meet the required specifications for degradation and impurity levels.
Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if they have been using this medication.
The recalled product
- Product
- ANAGRELIDE (ANAGRELIDE)
- Brand
- ANAGRELIDE
- Manufacturer
- Torrent Pharma Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 2,472
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 #: BFE2E003
- Exp 08/31/2020
UPCs (2)
- 0313668453300
- 0313668462302
Distribution
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