Recalls / Class III
Class IIID1151-2015
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.
- Affected lot / code info
- Lot #: T142A14A, T143A14A, T144A14A, Exp 01/16
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.
Recalling firm
- Firm
- Qualitest Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 120 Vintage Dr NE, Huntsville, Alabama 35811-8216
Distribution
- Quantity
- 2016 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-06-18
- FDA classified
- 2015-06-30
- Posted by FDA
- 2015-07-08
- Terminated
- 2016-10-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D1151-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.