FDA-Drug2012-11-28Class I
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
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Hazard
Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Sold states
Nationwide.
Affected count
14,445 bottles
Manufactured in
120 Vintage Dr NE, N/A, Huntsville, AL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-057-2013Don't want to check this manually?
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