FDA-Drug2017-10-25Class II

Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa 403 722 INDIA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-5858-61.

The Harvard Drug Group
Hazard

Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.

Sold states
Nationwide in the USA
Affected count
3,935 cartons
Manufactured in
17177 N Laurel Park Dr Ste 233, Livonia, MI, United States
Products
Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa 403 722 INDIA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-5858-61.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0013-2018

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