FDA recall D-1285-2015

Actavis Laboratories, FL, Inc. · Class III · drug

Product

Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles, Rx Only. Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by Actavis Pharma, Inc. Parsippany, NJ 07054 USA. NDC: 0591-2464-01.

Reason for recall

Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.

Distribution

U.S. Nationwide including Puerto Rico.

Key facts

Status
Terminated
Initiation date
2015-06-23
Report date
2015-08-12
Termination date
2016-12-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Davie, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1285-2015