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Class II: temporary or reversible health riskTerminated

Qualitest Pharmaceuticals OXYCODONE and ACETAMINOPHEN Recall

OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured…

Qualitest Pharmaceuticals · Huntsville, AL

Risk level
Class II
Reported by FDA
Sep 10, 2014
Recall ID
D-1572-2014
Check your lot numberHow we source this data

Summary

Qualitest Pharmaceuticals recalled OXYCODONE and ACETAMINOPHEN starting Aug 27, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1572-2014 on Sep 10, 2014. Reason: Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles. Status: Terminated.

Why it was recalled

Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles.

Product description

OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-4982-21

Lot numbers, UPCs & expiration codes

T062A14A, Exp 12/15

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1572-2014
Classification
Class II
Status
Terminated
Recall initiated
Aug 27, 2014
FDA report date
Sep 10, 2014
Quantity
23,544 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Qualitest Pharmaceuticals

Original FDA data

Every field from FDA enforcement report D-1572-2014, exactly as published.

Show all FDA fields
City
Huntsville
State
AL
Status
Terminated
Country
United States
Event ID
69157
Address
120 Vintage Dr NE
Code information
T062A14A, Exp 12/15
Postal code
35811-8216
Report date
Sep 10, 2014
Product type
Drugs
Recall number
D-1572-2014
Classification
Class II
Recalling firm
Qualitest Pharmaceuticals
Product quantity
23,544 bottles
Termination date
Feb 1, 2016
Reason for recall
Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles.
Voluntary / mandated
Voluntary: Firm initiated
Product description
OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-4982-21
Distribution pattern
Nationwide
Recall initiation date
Aug 27, 2014
Initial firm notification
Letter
Center classification date
Sep 3, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1572-2014, published Sep 10, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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