Drug product
20 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8494, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-494-61
D-1410-2016
Product summary
- Event
- Event 74057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25 bags
- Official record key
drug-enforcement:D-1410-2016
Official wording
Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Code information: Lot Number 160530134M , Exp. Date 5/23/2016 ; Lot Number 160630039M , Exp. Date 6/1/2016 ; Lot Number 160900044M , Exp. Date 6/28/2016 ;
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter