Drug Enforcement D-128-2013

Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life

Status

Terminated

Classification

Class III

Report Date

January 23, 2013

Termination Date

December 18, 2013

Product Information

Product description
CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 NDC 0093-5420-88
Product quantity
13,232 bottles
Reason for recall
Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

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-128-2013
Event ID
61725
Recall initiation date
April 24, 2012
Center classification date
January 16, 2013
Code info
Lot number 6A007046V, exp 07/12
More code info
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