Recalls / Class II
Class IID-247-2013
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.
- Brand name
- Cefdinir
- Generic name
- Cefdinir
- Active ingredient
- Cefdinir Monohydrate
- Route
- Oral
- NDCs
- 0093-4136, 0093-4137
- FDA application
- ANDA065332
- Affected lot / code info
- a) Lot #: 30304253A, Exp 12/13; b) Lot #: 30304144A, Exp 12/13 and 30304477A, Exp 03/14
Why it was recalled
Defective Container: This recall is being carried out due to the potential for improperly sealed bottles.
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 650 Cathill Rd, Sellersville, Pennsylvania 18960-1512
Distribution
- Quantity
- 62,187 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-02-26
- FDA classified
- 2013-04-10
- Posted by FDA
- 2013-04-17
- Terminated
- 2014-01-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-247-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.