D-0429-2018 Class II Terminated

Recalled by Pharmedium Services, LLC — Lake Forest, IL

FDA drug recall D-0429-2018 was initiated by Pharmedium Services, LLC on December 27, 2017 and is designated Class II. Reason for recall: Lack of sterility assurance. The recall status is terminated (terminated May 7, 2020). Affected quantity: 297 bags.

Recall Details

Product Type
Drugs
Report Date
February 28, 2018
Initiation Date
December 27, 2017
Termination Date
May 7, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
297 bags

Product Description

Bupivacaine HCl in 0.9% Sodium Chloride in all doses, all strengths, and packaging.

Reason for Recall

Lack of sterility assurance.

Distribution Pattern

U.S.A. Nationwide

Code Information

All lots remaining within expiry.