FDA Recall D-0166-2021
Torrent Pharma Inc · Levittown, PA
Class I — life-threatening Terminated 763 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence 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
Reason for recall
Failed Dissolution Specifications
Recall record
- Recall number
D-0166-2021- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide USA and Puerto Rico
- Recall initiated
- 2020-11-25
- Classified by FDA Center
- 2020-12-16
- FDA published
- 2020-12-09
- Terminated
- 2022-12-28
- Recalling firm
- Torrent Pharma Inc
- Firm location
- Levittown, PA
Drug identification
- Brand name(s)
- ANAGRELIDE
- Generic name(s)
- ANAGRELIDE
- Manufacturer(s)
- Torrent Pharmaceuticals Limited
- NDC(s)
13668-453, 13668-462- Route(s)
- ORAL