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Class III: unlikely to cause harmTerminated

Qualitest Pharmaceuticals Disulfiram tablets Recall

Disulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for and by Qu…

Qualitest Pharmaceuticals · Huntsville, AL

Risk level
Class III
Reported by FDA
Jul 8, 2015
Recall ID
D1151-2015
Check your lot numberHow we source this data

Summary

Qualitest Pharmaceuticals recalled Disulfiram tablets starting Jun 18, 2015. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D1151-2015 on Jul 8, 2015. Reason: Failed Dissolution Specifications: During routine stability testing at the 12 month time point, one product lot was found to be out of specification for dissolution. Status: Terminated.

Why it was recalled

Failed Dissolution Specifications: During routine stability testing at the 12 month time point, one product lot was found to be out of specification for dissolution.

Product description

Disulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for and by Qualitest Pharmaceuticals 130 Vintage Drive Huntsville, AL 35811. NDC 0603-3432-21.

Lot numbers, UPCs & expiration codes

Lot #: T142A14A, T143A14A, T144A14A, Exp 01/16

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
D1151-2015
Classification
Class III
Status
Terminated
Recall initiated
Jun 18, 2015
FDA report date
Jul 8, 2015
Quantity
2016 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Qualitest Pharmaceuticals

Original FDA data

Every field from FDA enforcement report D1151-2015, exactly as published.

Show all FDA fields
City
Huntsville
State
AL
Status
Terminated
Country
United States
Event ID
71563
Address
120 Vintage Dr NE
Code information
Lot #: T142A14A, T143A14A, T144A14A, Exp 01/16
Postal code
35811-8216
Report date
Jul 8, 2015
Product type
Drugs
Recall number
D1151-2015
Classification
Class III
Recalling firm
Qualitest Pharmaceuticals
Product quantity
2016 bottles
Termination date
Oct 23, 2016
Reason for recall
Failed Dissolution Specifications: During routine stability testing at the 12 month time point, one product lot was found to be out of specification for dissolution.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Disulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for and by Qualitest Pharmaceuticals 130 Vintage Drive Huntsville, AL 35811. NDC 0603-3432-21.
Distribution pattern
Nationwide
Recall initiation date
Jun 18, 2015
Initial firm notification
Letter
Center classification date
Jun 30, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D1151-2015, published Jul 8, 2015. 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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