D-1862-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 25, 2019
- Initiation Date
- September 6, 2019
- Termination Date
- November 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2472 bottles
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
Lot #: BFE2E003, Exp 08/31/2020