FDAClass INovember 28, 2012

Hydrocodone Bitartrate and Acetaminophen Tablets recall: Superpotent

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

Why was Hydrocodone Bitartrate and Acetaminophen Tablets recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot number: C1440512A, Exp 12/13

Product
HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL…
Recalling firm
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Quantity
14,445 bottles
Distribution
Nationwide.
Recall date
November 28, 2012
Classification
Class I
Status
Ongoing
Agency
FDA (drug)
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