Drug Enforcement D-0394-2024

Lack of Assurance of Sterility

Status

Terminated

Classification

Class II

Report Date

April 3, 2024

Termination Date

August 27, 2024

Product Information

Product description
Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095; NDC 70004-0541-35, Bar Code 70004054135
Product quantity
381 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-0394-2024
Event ID
93456
Recall initiation date
November 9, 2023
Center classification date
March 22, 2024
Code info
Lot #: 1223049625, Exp 1/24/24
More code info
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