Why it was recalled
Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product.
Product description
Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g in 25 ml fliptop vial, 10-count tray, Rx only, Manufactured by Hospira, Inc. Lake Forest, IL 60045, NDC 0409-6533-01.
Lot numbers, UPCs & expiration codes
Lot# 43-240-DD; Exp. 07/16 Lot# 44-205-DD,44-455-DD,44-460-DD,44-465-DD; Exp. 08/16
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-0254-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 7, 2014
- FDA report date
- Nov 26, 2014
- Quantity
- 316,640 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-0254-2015, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 69659
- Address
- 275 N Field Dr
- Code information
- Lot# 43-240-DD; Exp. 07/16 Lot# 44-205-DD,44-455-DD,44-460-DD,44-465-DD; Exp. 08/16
- Postal code
- 60045-2579
- Report date
- Nov 26, 2014
- Product type
- Drugs
- Recall number
- D-0254-2015
- Classification
- Class III
- Recalling firm
- Hospira Inc.
- Product quantity
- 316,640 vials
- Termination date
- Mar 22, 2017
- Reason for recall
- Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g in 25 ml fliptop vial, 10-count tray, Rx only, Manufactured by Hospira, Inc. Lake Forest, IL 60045, NDC 0409-6533-01.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Nov 7, 2014
- Initial firm notification
- Letter
- Center classification date
- Nov 19, 2014