Drug Enforcement D-0413-2024

Lack of Assurance of Sterility

Status

Terminated

Classification

Class II

Report Date

April 3, 2024

Termination Date

August 27, 2024

Product Information

Product description
neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0750-09, Bar Code 70004075009
Product quantity
1,122 syringes
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-0413-2024
Event ID
93456
Recall initiation date
November 9, 2023
Center classification date
March 22, 2024
Code info
Lot #: 1223048138 exp 1/31/24
More code info
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