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D-1448-2016 Class II Terminated

Recalled by Actavis Inc — Parsippany, NJ

FDA drug recall D-1448-2016 was initiated by Actavis Inc on Jul 11, 2016 and is designated Class II. Reason for recall: Failed Dissolution Specifications The recall status is terminated (terminated Feb 16, 2017). Affected quantity: 8,062 units.

Recall details

Product Type: Drugs
Report Date: Aug 3, 2016
Initiation Date: Jul 11, 2016
Termination Date: Feb 16, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 8,062 units

Product description

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

Distribution pattern

Nationwide

Code information

Lot #: 3803J141, Exp. 7/2016

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1448-2016
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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