FDA recall D-0992-2022

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.

Distribution

Distributed Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-05-11

Report date

2022-06-08

Termination date

2024-02-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0992-2022