Recalls / Class III
Class IIID-0254-2015
Product
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.
- Brand name
- Vancomycin Hydrochloride
- Generic name
- Vancomycin Hydrochloride
- Active ingredient
- Vancomycin Hydrochloride
- Route
- Intravenous
- NDCs
- 0409-3515, 0409-6531, 0409-6533, 0409-4332
- FDA application
- ANDA062912
- Affected lot / code info
- Lot# 43-240-DD; Exp. 07/16 Lot# 44-205-DD,44-455-DD,44-460-DD,44-465-DD; Exp. 08/16
Why it was recalled
Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 316,640 vials
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2014-11-07
- FDA classified
- 2014-11-19
- Posted by FDA
- 2014-11-26
- Terminated
- 2017-03-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0254-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.