FDA recall D-058-2013

Product

Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05.

Reason for recall

Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2012-09-21

Report date

2012-11-28

Termination date

2014-03-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Corona, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-058-2013