Drug Enforcement D-1516-2022

Lack of Assurance of Sterility

1 Views

Status

Completed

Classification

Class II

Report Date

September 21, 2022

Termination Date

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Product Information

Product description
MIC/B12 25/50/50/1 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Product quantity
3 vials
Reason for recall
Lack of Assurance of Sterility
Recall initiation reason
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Initial firm notification
E-Mail
Distribution pattern
Nationwide in the USA.

Location & Firm

Recalling firm
Carolina Infusion
Address
95 Bees Creek Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-1516-2022
Event ID
90798
Recall initiation date
August 26, 2022
Center classification date
September 15, 2022
Code info
Lots: 08012022@4 BUD: 01/28/2023; 08082022@12 BUD: 02/04/2023
More code info
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