Torrent Pharma Recalls Anagrelide Capsules Due to Failed Dissolution Specifications
Torrent Pharma Inc. is recalling 2,496 bottles of Anagrelide Capsules, USP 1 mg, because the product failed to meet dissolution specifications.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA has classified this recall as Class I, which indicates a reasonable probability that use of or exposure to the violative product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a severity score of 4 or 5; in the absence of reported deaths or serious injuries, the score is 4.
Plain-English summary
Torrent Pharma Inc. is recalling 2,496 bottles of Anagrelide Capsules, USP 1 mg, NDC 13668-462-01. The recall is being conducted because the product failed to meet dissolution specifications. The affected product is Batch BFD1G001 with an expiration date of 12/2021.
The recalled product was distributed nationwide in the United States and Puerto Rico. Anagrelide is a prescription-only medication manufactured in India for Torrent Pharma Inc. in Basking Ridge, NJ.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions. The recall is classified as Class I by the FDA.
The recalled product
- Product
- ANAGRELIDE (ANAGRELIDE)
- Brand
- ANAGRELIDE
- Manufacturer
- Torrent Pharma Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 2,496
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)
- Batch BFD1G001
- exp 12/2021
UPCs (2)
- 0313668453300
- 0313668462302
Distribution
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