Drug product
PHENYLephrine HCl, 50 mg added to 250 mL 0.9% Sodium Chloride Injection USP (200 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-171-50
D-1821-2015
Product summary
- Event
- Event 71844
- Status
- Terminated
- Classification
- Class I
- Quantity
- 240 bags
- Official record key
drug-enforcement:D-1821-2015
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 #: 14310039S, Exp 11/06/14; 14318006S, Exp 11/17/14; 14321060S, Exp11/07/14
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter