FDA-Drug2014-03-12Class II

Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx only, Manufactured by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-3086-06, UPC 3 0228-3086-06 2.

Actavis Elizabeth LLC
Hazard

Failed Dissolution Specifications: Product did not meet specification requirements for dissolution.

Sold states
Nationwide
Affected count
5,148 bottles
Manufactured in
200 Elmora Ave, Elizabeth, NJ, United States
Products
Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx only, Manufactured by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-3086-06, UPC 3 0228-3086-06 2.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1091-2014

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