Reported Nov 28, 2012 · Ongoing

HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST…

Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals · 120 Vintage Dr NE · Huntsville, AL · 35811-8216

Is this the product you have?

  • HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg
  • forQUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21
Lot codes and dates
  • Lot number
    • C1440512A
    • Exp 12/13
Amount recalled
14,445 bottles

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

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

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 7:59 PM UTC

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