Drug Enforcement D-396-2014

Failed Tablet/Capsule Specifications: There is a potential for broken tablets.

Status

Terminated

Classification

Class II

Report Date

January 8, 2014

Termination Date

August 27, 2014

Product Information

Product description
Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., Sellersville, PA, 18960, NDC 0093-7392-98
Product quantity
10,512 bottles
Reason for recall
Failed Tablet/Capsule Specifications: There is a potential for broken tablets.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide and Puerto Rico, American Samoa, Virgin Islands, and Canal Zone

Location & Firm

Recalling firm
Teva Pharmaceuticals USA
Address
425 Privet Rd

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

Codes & Dates

Recall number
D-396-2014
Event ID
66955
Recall initiation date
November 26, 2013
Center classification date
January 2, 2014
Code info
Lot#: 32900349B, Exp: 12/2014
More code info
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