Drug product
Fentanyl Citrate, 5 mcg per mL (1,250 mcg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV Use Only, Rx only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-107-50
D-1825-2015
Product summary
- Event
- Event 71844
- Status
- Terminated
- Classification
- Class I
- Quantity
- 663 bags
- Official record key
drug-enforcement:D-1825-2015
Official wording
Reason: Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Code information: Lot #: 14303122M, Exp 01/28/15; 14309029M, Exp 02/02/15; 14315067M, Exp 02/09/15; 14317040M, Exp 02/11/15; 14318026M, Exp 02/12/15; 14323089M, Exp 02/17/15; 14325128M, 14325124M, Exp 02/19/15
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter