FDA-Drug2013-12-04Class II

Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., Elizabeth, NJ, NDC 0228-4025-11

Actavis Elizabeth LLC
Hazard

Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets

Sold states
Nationwide
Affected count
756 bottles
Manufactured in
200 Elmora Ave, N/A, Elizabeth, NJ, United States
Products
Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., Elizabeth, NJ, NDC 0228-4025-11

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-018-2014

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