Drug Enforcement D-1703-2012

Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.

Status

Terminated

Classification

Class III

Report Date

October 10, 2012

Termination Date

March 29, 2013

Product Information

Product description
Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01
Product quantity
31,867 Bottles
Reason for recall
Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide and PR

Location & Firm

Recalling firm
Mylan Pharmaceuticals Inc.
Address
781 Chestnut Ridge Rd, N/A

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

Codes & Dates

Recall number
D-1703-2012
Event ID
62911
Recall initiation date
June 28, 2012
Center classification date
September 28, 2012
Code info
Lot: 3018952, Exp 08/12
More code info
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