D-0992-2022 Class I Terminated
FDA drug recall D-0992-2022 was initiated by Teva Pharmaceuticals USA Inc on May 11, 2022 and is designated Class I. Reason for recall: Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing. The recall status is terminated (terminated Feb 26, 2024). Affected quantity: 4224 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 8, 2022
- Initiation Date
- May 11, 2022
- Termination Date
- Feb 26, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4224 cartons
Product Description
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.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Lot # GD01090, Exp 05/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0992-2022
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026