FDA recall D-1053-2014

Product

Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, 100 count bottles, Rx only. Manufactured by Watson Laboratories, Inc., Corona, CA 92880. Distributed by: Watson Pharma, Inc. NDC: 00591-0517-01.

Reason for recall

Failed Tablet/Capsule Specifications; Product contains broken tablets.

Distribution

Nationally in: AZ, CA, CT, FL, NV, OH, OK, PA, SC, WI.

Key facts

Status

Terminated

Initiation date

2014-01-15

Report date

2014-02-05

Termination date

2014-07-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Corona, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1053-2014