FDA recall D-0013-2018

Product

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.

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2017-09-26

Report date

2017-10-25

Termination date

2020-04-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Livonia, MI, United States

Primary source

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