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.

FDA recall notice · announced April 17, 2013 · Teva Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Reason for recall

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

Notes

Distribution: Nationwide
Lot/code information: a) Lot #: 30304253A, Exp 12/13; b) Lot #: 30304144A, Exp 12/13 and 30304477A, Exp 03/14
Quantity: 62,187 bottles
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.