FDA Recall D-0638-2017
Hospira Inc., A Pfizer Company · Lake Forest, IL
Class I — life-threatening Terminated 457 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, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous Use, packaged in 100 mL glass vial, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6510-01
Reason for recall
Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product.
Recall record
- Recall number
D-0638-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- U.S. Nationwide
- Recall initiated
- 2017-01-24
- Classified by FDA Center
- 2017-04-05
- FDA published
- 2017-04-12
- Terminated
- 2018-04-26
- Recalling firm
- Hospira Inc., A Pfizer Company
- Firm location
- Lake Forest, IL