Recalls / Class I
Class ID-0992-2022
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, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454. NDC 0172-5241-60.
- Affected lot / code info
- Lot # GD01090, Exp 05/2022
Why it was recalled
Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
Recalling firm
- Firm
- Teva Pharmaceuticals USA Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy Bldg A, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 4224 cartons
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2022-05-11
- FDA classified
- 2022-06-08
- Posted by FDA
- 2022-06-08
- Terminated
- 2024-02-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0992-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.