Critical FDA (Drugs)·D-138-2013·Announced 2013-02-06

Qualitest Recalls Hydrocodone and Acetaminophen Tablets Due to Oversized Size

Qualitest Pharmaceuticals is recalling 897,379 bottles of Hydrocodone bitartrate and acetaminophen tablets because a complaint reported the tablets were oversized.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source metadata explicitly identifies the agency classification as FDA Class I, which mandates a severity score of 5 (Critical) according to the rubric.

Plain-English summary

Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals is recalling 897,379 bottles of Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg. The recall was initiated after a complaint was received regarding oversized tablets. The affected product is available in 30, 60, 90, 100, 120, 150, 180, 500, and 1,000-count bottles and is distributed nationwide and in Puerto Rico.

The recall covers all lots beginning with the letter "C" with expiration dates of 12/13. Specific lot numbers include C1160712C, C0930812A, C1110412A, and many others listed in the official recall documentation. The product is manufactured for Qualitest Pharmaceuticals in Huntsville, AL.

Consumers with this product should contact their pharmacist or healthcare provider for guidance. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.

The recalled product

Product: Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b) 60-count bottles, NDC 0603-3888-20; c) 90-count bottles, NDC 0603-3888-02; d) 100-count bottles, NDC 0603-3888-21; e) 120-count bottles, NDC 0603-3888-22; f)
Manufacturer: Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Category: Drug — Prescription Medication
Hazard: oversized-tablet
Affected units: 897,379

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Lot #: All that begin with the letter "C" a) C1160712C
Exp 12/13
b) C0930812A
C1110412A
C1141012B
C1160712A
c) C0950812B
C1110412B
C1151012B
C1160712B
C1530512A
d) C0540212A
C0550212A
C0560212A
C0710312A
C0720312A
C0730112B
C0730312A
C0740112B
C0740312A

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals

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