Recalls / Class II
Class IID-1862-2019
Product
Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-453-01.
- 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
- Lot #: BFE2E003, Exp 08/31/2020
Why it was recalled
Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
Recalling firm
- Firm
- Torrent Pharma Inc.
- Manufacturer
- Torrent Pharmaceuticals Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 150 Allen Rd Ste 102, N/A, Basking Ridge, New Jersey 07920-3856
Distribution
- Quantity
- 2472 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2019-09-06
- FDA classified
- 2019-09-16
- Posted by FDA
- 2019-09-25
- Terminated
- 2020-11-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1862-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.