Drug product
0.05 mg/mL Morphine Sulfate and 0.0625% Bupivacaine HCI (Preservative Free) in 0.9% Sodium Chloride, 250 mL Hospira LifeCare bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-995-54 ,
D-1361-2016
Product summary
- Event
- Event 74057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 80 bags
- Official record key
drug-enforcement:D-1361-2016
Official wording
Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Code information: Lot # 160420165M; Exp. 05/16 Lot # 160540128M; Exp. 05/16 Lot # 160630117M; Exp. 06/16 Lot # 160770157M; Exp. 06/16 Lot # 160870055M; Exp. 06/16 Lot # 160890153M; Exp. 06/16 Lot # 160950340M; Exp. 07/16
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter