FDA recall D-057-2013

Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals · Class I · drug

Product

HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21

Reason for recall

Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.

Distribution

Nationwide.

Key facts

Status: Ongoing
Initiation date: 2012-09-10
Report date: 2012-11-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Huntsville, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-057-2013