Drug Enforcement D-246-2013

Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.

Status

Terminated

Classification

Class III

Report Date

April 17, 2013

Termination Date

January 15, 2014

Product Information

Product description
Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 91-count tablets per extended-cycle tablet dispenser packaged in 3 dispensers per carton, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66.
Product quantity
71,893 dispensers
Reason for recall
Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

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

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

Codes & Dates

Recall number
D-246-2013
Event ID
64607
Recall initiation date
March 12, 2013
Center classification date
April 10, 2013
Code info
Lot #: 33803603A, 33803604A, Exp 11/13; 33803996A, and 33803997A, Exp 03/14
More code info
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