Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA; Distributed by: Actavis Pharma, Inc Parsippany, NJ 07054 USA NDC 45963-304-09

FDA recall notice · announced August 3, 2016 · Actavis

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA; Distributed by: Actavis Pharma, Inc Parsippany, NJ 07054 USA NDC 45963-304-09

Reason for recall

Failed Dissolution Specifications

Notes

Distribution: Nationwide
Lot/code information: Lot #: 3803J141, Exp. 7/2016
Quantity: 8,062 units
Status: Terminated
Products in this recall event:
- Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA; Distributed by: Actavis Pharma, Inc Parsippany, N (D-1448-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.