FDA-Drug2022-06-08Class I

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.

Teva Pharmaceuticals USA Inc
Hazard

Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.

Sold states
Distributed Nationwide in the USA
Affected count
4224 cartons
Manufactured in
400 Interpace Pkwy Bldg A, N/A, Parsippany, NJ, United States
Products
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.

Official notice

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

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