FDA-Drug2015-03-11Class II

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.

Actavis Elizabeth LLC
Hazard

Failed Dissolution Specifications

Sold states
Nationwide
Affected count
42 bottles
Manufactured in
200 Elmora Ave, N/A, Elizabeth, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0395-2015

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