Drug Enforcement D-690-2013

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

Status

Terminated

Classification

Class III

Report Date

July 17, 2013

Termination Date

January 15, 2014

Product Information

Product description
Camila (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0715-58
Product quantity
59,240 Cartons
Reason for recall
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide and Puerto Rico

Location & Firm

Recalling firm
Teva Pharmaceuticals USA, Inc.
Address
650 Cathill Rd, N/A

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

Codes & Dates

Recall number
D-690-2013
Event ID
64643
Recall initiation date
March 15, 2013
Center classification date
July 11, 2013
Code info
Lot #s: 33802107A, 33802108A, Exp 9/13; 33802109A, 33802110A, 33802111A, 33802112A, Exp10/13; 33802560A, Exp 1/14.
More code info
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