Drug product
0.03% Bupivacaine HCl (Preservative Free) in Sodium Chloride 0.9%, 250 mL Medical Cassette Reservoir, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-931-11
D-1360-2016
Product summary
- Event
- Event 74057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 177 Medical Cassettes
- Official record key
drug-enforcement:D-1360-2016
Official wording
Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Code information: Lot # 160410097M; Exp. 05/16 Lot # 160420107M; Exp. 05/16 Lot # 160460117M; Exp. 05/16 Lot # 160530133M; Exp. 05/16 Lot # 160540206M; Exp. 05/16 Lot # 160570008M; Exp. 05/16 Lot # 160670132M; Exp. 06/16 Lot # 160700001C; Exp. 06/16 Lot # 160770020C; Exp. 06/16 Lot # 160900103C; Exp. 06/16
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter