FDA recall D-1061-2013

Product

Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 Count Bottle, Manufactured by: Watson Laboratories, Inc, Cocona, CA 92880, NDC 0591-2611-05.

Reason for recall

Defective Container: Defective bottles may not have tamper evident seals properly seated, and therefore it may be difficult to determine if the product had been opened or tampered with.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-08-30

Report date

2013-09-25

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-1061-2013