Drug Enforcement D-1677-2012

Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.

Status

Terminated

Classification

Class III

Report Date

September 26, 2012

Termination Date

April 10, 2013

Product Information

Product description
Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781- 5249-92,
Product quantity
43,060 x 90 count bottles
Reason for recall
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Sandoz Incorporated
Address
2555 W Midway Blvd

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

Codes & Dates

Recall number
D-1677-2012
Event ID
63160
Recall initiation date
September 12, 2012
Center classification date
September 19, 2012
Code info
Lot numbers: BJ3338; BJ3339; BJ 3340; BJ3341; BJ3342; BJ6282; BJ7192; BM8498; BJ7202; BJ7203, Exp 12/12
More code info
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