Why it was recalled
Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the fill tube seal.
Product description
METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 (NDC 0409-7811-24)
Lot numbers, UPCs & expiration codes
Lot code 12-074-JT Exp 12/13
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-206-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 15, 2013
- FDA report date
- Mar 27, 2013
- Quantity
- 567,624 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-206-2013, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 64482
- Address
- 275 N Field Dr
- Code information
- Lot code 12-074-JT Exp 12/13
- Postal code
- 60045-2579
- Report date
- Mar 27, 2013
- Product type
- Drugs
- Recall number
- D-206-2013
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 567,624 bags
- Termination date
- Mar 31, 2015
- Reason for recall
- Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the fill tube seal.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 (NDC 0409-7811-24)
- Distribution pattern
- Nationwide.
- Recall initiation date
- Feb 15, 2013
- Initial firm notification
- Letter
- Center classification date
- Mar 21, 2013