Why it was recalled
Defective Container: This recall is being carried out due to the potential for improperly sealed bottles.
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.
Lot numbers, UPCs & expiration codes
a) Lot #: 30304253A, Exp 12/13; b) Lot #: 30304144A, Exp 12/13 and 30304477A, Exp 03/14
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-247-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 26, 2013
- FDA report date
- Apr 17, 2013
- Quantity
- 62,187 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
Original FDA data
Every field from FDA enforcement report D-247-2013, exactly as published.
Show all FDA fields
- City
- Sellersville
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 64480
- Address
- 650 Cathill Rd
- Code information
- a) Lot #: 30304253A, Exp 12/13; b) Lot #: 30304144A, Exp 12/13 and 30304477A, Exp 03/14
- Postal code
- 18960-1512
- Report date
- Apr 17, 2013
- Product type
- Drugs
- Recall number
- D-247-2013
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Product quantity
- 62,187 bottles
- Termination date
- Jan 15, 2014
- Reason for recall
- Defective Container: This recall is being carried out due to the potential for improperly sealed bottles.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 26, 2013
- Initial firm notification
- Letter
- Center classification date
- Apr 10, 2013