Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabeth LLC, Elizabeth, NJ 07201 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 45963-305-09, UPC 3 45963-305-09 1.
Reported: March 11, 2015 Initiated: February 10, 2015 #D-0395-2015
Product Description
Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabeth LLC, Elizabeth, NJ 07201 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 45963-305-09, UPC 3 45963-305-09 1.
Reason for Recall
Failed Dissolution Specifications
Details
- Recalling Firm
- Actavis Elizabeth LLC
- Units Affected
- 42 bottles
- Distribution
- Nationwide
- Location
- Elizabeth, NJ
Frequently Asked Questions
What product was recalled? ▼
Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabeth LLC, Elizabeth, NJ 07201 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 45963-305-09, UPC 3 45963-305-09 1.. Recalled by Actavis Elizabeth LLC. Units affected: 42 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 11, 2015. Severity: Moderate. Recall number: D-0395-2015.
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