Drug product
0.4 mcg/mL Sufentanil Citrate and 0.0625% Bupivacaine HCl (Preservative Free), 150 mL in 150 mL Baxter Intravia Bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-713-95
D-1369-2016
Product summary
- Event
- Event 74057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 140 bags
- Official record key
drug-enforcement:D-1369-2016
Official wording
Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Code information: Lot Number: 160970109M, Exp. Date 5/7/2016
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter