Bupivacaine HCl in 0.9% Sodium Chloride in all doses, all strengths, and packaging.
FDA Recall #D-0429-2018 — Class II — December 27, 2017
Product Description
Bupivacaine HCl in 0.9% Sodium Chloride in all doses, all strengths, and packaging.
Reason for Recall
Lack of sterility assurance.
Recalling Firm
Pharmedium Services, LLC — Lake Forest, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
297 bags
Distribution
U.S.A. Nationwide
Code Information
All lots remaining within expiry.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated