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
Reported: April 12, 2017 Initiated: January 24, 2017 #D-0638-2017
Product Description
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.
Details
- Recalling Firm
- Hospira Inc., A Pfizer Company
- Units Affected
- 30,880 vials
- Distribution
- U.S. Nationwide
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Hospira Inc., A Pfizer Company. Units affected: 30,880 vials.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 12, 2017. Severity: Critical. Recall number: D-0638-2017.
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