Drug Enforcement D-0425-2024

Lack of Assurance of Sterility

Status

Terminated

Classification

Class II

Report Date

April 3, 2024

Termination Date

August 27, 2024

Product Information

Product description
VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0923-59, Bar Code 70004092359
Product quantity
368 bags
Reason for recall
Lack of Assurance of Sterility
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
SCA Pharmaceuticals, LLC
Address
755 Rainbow Rd Ste B, N/A

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

Codes & Dates

Recall number
D-0425-2024
Event ID
93456
Recall initiation date
November 9, 2023
Center classification date
March 22, 2024
Code info
Lot #: 1223049049 Exp 12/28/23
More code info
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