Recalls / Class I
Class ID-0638-2017
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, 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
- Affected lot / code info
- Lot # 591053A, Exp 11/1/2017
Why it was recalled
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.
Recalling firm
- Firm
- Hospira Inc., A Pfizer Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 30,880 vials
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2017-01-24
- FDA classified
- 2017-04-05
- Posted by FDA
- 2017-04-12
- Terminated
- 2018-04-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0638-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.