The Recall Desk
ModerateFDA (Drugs)·D-247-2013·Announced 2013-04-17

Teva Recalls Cefdinir Oral Suspension Due to Improperly Sealed Bottles

Teva Pharmaceuticals is recalling 62,187 bottles of Cefdinir for Oral Suspension because some bottles may be improperly sealed.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a defective container (improperly sealed bottles) without reported illnesses or injuries, fitting the criteria for a moderate severity recall.

Plain-English summary

Teva Pharmaceuticals USA, Inc. is recalling 62,187 bottles of Cefdinir for Oral Suspension, 125 mg/5 mL. The affected product is available in 60 mL and 100 mL bottles and was distributed nationwide. The recall is being conducted due to the potential for improperly sealed bottles.

The specific lots affected are 30304253A (expiration 12/13), 30304144A (expiration 12/13), and 30304477A (expiration 03/14). The product is a prescription-only medication manufactured by Teva Pharmaceuticals USA, Inc. in Sellersville, PA.

Consumers should check their medication bottles for the lot numbers and expiration dates listed above. If the product matches the recalled description, they should stop using it and contact their healthcare provider or pharmacist for instructions on how to dispose of the medication or obtain a replacement.

The recalled product

Product
CEFDINIR (CEFDINIR)
Brand
CEFDINIR
Affected units
62,187

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • a) Lot #: 30304253A
  • Exp 12/13
  • b) Lot #: 30304144A
  • Exp 12/13 and 30304477A
  • Exp 03/14

Distribution

Distributed nationwide across the United States.