D-0429-2018 Class II Terminated
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.