FDA Recall D-0992-2022
Teva Pharmaceuticals USA Inc · Parsippany, NJ
Class I — life-threatening Terminated 656 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454. NDC 0172-5241-60.
Reason for recall
Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
Recall record
- Recall number
D-0992-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Distributed Nationwide in the USA
- Recall initiated
- 2022-05-11
- Classified by FDA Center
- 2022-06-08
- FDA published
- 2022-06-08
- Terminated
- 2024-02-26
- Recalling firm
- Teva Pharmaceuticals USA Inc
- Firm location
- Parsippany, NJ