Drug product
10 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8480, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-480-50
D-1385-2016
Product summary
- Event
- Event 74057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 bags
- Official record key
drug-enforcement:D-1385-2016
Official wording
Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Code information: Lot # 160890042M; Exp. Date 5/13/2016 Lot # 160960052M; Exp. Date 5/20/2016
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter