Drug Enforcement D-247-2013

Defective Container: This recall is being carried out due to the potential for improperly sealed bottles.

Status

Terminated

Classification

Class II

Report Date

April 17, 2013

Termination Date

January 15, 2014

Product Information

Product description
Cefdinir for Oral Suspension, 125 mg/5 mL, packaged in a) 60 mL bottle (NDC 0093-4136-64); b) 100 mL bottle (NDC 0093-4136-73), Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960.
Product quantity
62,187 bottles
Reason for recall
Defective Container: This recall is being carried out due to the potential for improperly sealed bottles.
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-247-2013
Event ID
64480
Recall initiation date
February 26, 2013
Center classification date
April 10, 2013
Code info
a) Lot #: 30304253A, Exp 12/13; b) Lot #: 30304144A, Exp 12/13 and 30304477A, Exp 03/14
More code info