Recalls / Class I
Class ID-0123-2018
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Vancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only. Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-6531-02
- 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: 632153A; Exp. 03/18
Why it was recalled
Presence of Particulate Matter: glass particulate found in vial
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, New York, New York 10017-5703
Distribution
- Quantity
- 102,500 vials
- Distribution pattern
- Nationwide USA and Puerto Rico
Timeline
- Recall initiated
- 2017-08-30
- FDA classified
- 2017-12-20
- Posted by FDA
- 2017-12-27
- Terminated
- 2018-11-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0123-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.