Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540
Reported: September 23, 2015 Initiated: July 28, 2015 #D-1430-2015
Product Description
Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540
Reason for Recall
Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing.
Details
- Recalling Firm
- Novartis Pharmaceuticals Corp.
- Units Affected
- 10,767 bottles
- Distribution
- NJ - site for distributor
- Location
- Suffern, NY
Frequently Asked Questions
What product was recalled? ▼
Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540. Recalled by Novartis Pharmaceuticals Corp.. Units affected: 10,767 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 23, 2015. Severity: Low. Recall number: D-1430-2015.
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