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.

FDA recall notice · announced September 25, 2019 · Torrent Pharma

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: Nationwide in the USA and Puerto Rico
Lot/code information: Lot #: BFE2E003, Exp 08/31/2020
Quantity: 2472 bottles
Status: Terminated
Products in this recall event:
- 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. (D-1862-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.