Drug 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
D-0638-2017
Product summary
- Event
- Event 76284
- Status
- Terminated
- Classification
- Class I
- Quantity
- 30,880 vials
- Official record key
drug-enforcement:D-0638-2017
Official wording
Reason: 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.
Code information: Lot # 591053A, Exp 11/1/2017
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter