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
Product summary
- 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
out of specification