Product: 0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2N1488 (NDC 61553-488-11), 500 mL in 500 mL Baxter Intravia Bag, Service Code 2N1489 (NDC 61553-489-01)Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
Reason for recall: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Recall initiated: 20160505
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated