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.
Reported: July 8, 2015 Initiated: June 18, 2015 #D1151-2015
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.
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.
Details
- Recalling Firm
- Qualitest Pharmaceuticals
- Units Affected
- 2016 bottles
- Distribution
- Nationwide
- Location
- Huntsville, AL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Qualitest Pharmaceuticals. Units affected: 2016 bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 8, 2015. Severity: Low. Recall number: D1151-2015.
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