Drug product
10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-733-17
D-1383-2016
Product summary
- Event
- Event 74057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 55 bags
- Official record key
drug-enforcement:D-1383-2016
Official wording
Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Code information: Lot Number 160470116M , Exp. Date 5/17/2016 ; Lot Number 160490123M , Exp. Date 5/19/2016 ; Lot Number 160800048M , Exp. Date 6/18/2016 ; Lot Number 160890060M , Exp. Date 6/27/2016 ; Lot Number 160940050M , Exp. Date 7/2/2016 ;
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter