Why it was recalled
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Product description
Sodium Acetate Injection, USP, 40 mEq/20 ml (2 mEq/mL) 20 mL Single-Dose Fliptop, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-7299-73
Lot numbers, UPCs & expiration codes
Lot 23-320-DK and 23-321-DK Exp. 11/14
Where it was sold
Nationwide and Puerto Rico
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-316-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 26, 2013
- FDA report date
- May 15, 2013
- Quantity
- 266,900 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-316-2013, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 65077
- Address
- 275 N Field Dr
- Code information
- Lot 23-320-DK and 23-321-DK Exp. 11/14
- Postal code
- 60045-2579
- Report date
- May 15, 2013
- Product type
- Drugs
- Recall number
- D-316-2013
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 266,900 vials
- Termination date
- Nov 10, 2014
- Reason for recall
- Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sodium Acetate Injection, USP, 40 mEq/20 ml (2 mEq/mL) 20 mL Single-Dose Fliptop, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-7299-73
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Feb 26, 2013
- Initial firm notification
- Letter
- Center classification date
- May 6, 2013