FDA recall D-1430-2012

Product

Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1.

Reason for recall

Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2012-05-25

Report date

2012-08-08

Termination date

2015-04-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hobart, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1430-2012