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Recall Observatory FDA recall evidence

Drug product

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.

D1151-2015

June 18, 2015

Class III

Product summary

Firm
Qualitest Pharmaceuticals
Event
Event 71563
Status
Terminated
Classification
Class III
Quantity
2016 bottles
Official record key
drug-enforcement:D1151-2015

Official wording

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.

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

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification