FDA Recall D-0123-2018
Pfizer Inc. · New York, NY
Class I — life-threatening Terminated 435 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence 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
Reason for recall
Presence of Particulate Matter: glass particulate found in vial
Recall record
- Recall number
D-0123-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide USA and Puerto Rico
- Recall initiated
- 2017-08-30
- Classified by FDA Center
- 2017-12-20
- FDA published
- 2017-12-27
- Terminated
- 2018-11-08
- Recalling firm
- Pfizer Inc.
- Firm location
- New York, NY
Drug identification
- Brand name(s)
- VANCOMYCIN HYDROCHLORIDE
- Generic name(s)
- VANCOMYCIN HYDROCHLORIDE
- Manufacturer(s)
- Hospira, Inc.
- NDC(s)
0409-3515, 0409-6531, 0409-6533, 0409-4332- Route(s)
- INTRAVENOUS