Recalls / Class I
Class ID-0166-2021
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920 NDC 13668-462-01
- Brand name
- Anagrelide
- Generic name
- Anagrelide
- Active ingredient
- Anagrelide Hydrochloride Anhydrous
- Route
- Oral
- NDCs
- 13668-453, 13668-462
- FDA application
- ANDA209151
- Affected lot / code info
- Batch BFD1G001, exp 12/2021
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Torrent Pharma Inc
- Manufacturer
- Torrent Pharmaceuticals Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2091 Hartel Ave, N/A, Levittown, Pennsylvania 19057-4506
Distribution
- Quantity
- 2496 Bottles
- Distribution pattern
- Nationwide USA and Puerto Rico
Timeline
- Recall initiated
- 2020-11-25
- FDA classified
- 2020-12-16
- Posted by FDA
- 2020-12-09
- Terminated
- 2022-12-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0166-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.