Drug Enforcement D-175-2013

Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.

Status

Terminated

Classification

Class III

Report Date

March 6, 2013

Termination Date

January 13, 2014

Product Information

Product description
buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30 Actavis Distributed by: Actavis South Atlantic LLC Sunrise, FL 33325 Packaged by by: America Health Packaging Columbus, OH 43217
Product quantity
14,856 bottles
Reason for recall
Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Actavis Pharmaceuticals
Address
60 Columbia Rd Bldg B, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-175-2013
Event ID
64317
Recall initiation date
January 4, 2013
Center classification date
February 27, 2013
Code info
Lot CB1D05A,
More code info
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