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Recall Observatory FDA recall evidence

Drug product

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.

D-247-2013

February 26, 2013

Class II

Product summary

Firm
Teva Pharmaceuticals USA, Inc.
Event
Event 64480
Status
Terminated
Classification
Class II
Quantity
62,187 bottles
Official record key
drug-enforcement:D-247-2013

Official wording

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

Code information: a) Lot #: 30304253A, Exp 12/13; b) Lot #: 30304144A, Exp 12/13 and 30304477A, Exp 03/14

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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