Drug product
VANCOMYCIN HCl 1.5g in 300 mL 5% Dextrose Injection USP, Service Code 2K2227, NDC# 61553-027-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
D-0916-2017
Product summary
- Event
- Event 77191
- Status
- Terminated
- Classification
- Class II
- Quantity
- 108 bags
- Official record key
drug-enforcement:D-0916-2017
Official wording
Reason: Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Code information: Lot Numbers: 170250124S, 2/25/2017; 170270018S, 2/28/2017; 170380015S, 3/10/2017
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Labeling: Not Elsewhere Classified: Incorrect