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Recall Observatory FDA recall evidence

Drug product

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

D-0413-2024

November 09, 2023

Class II

Product summary

Firm
SCA Pharmaceuticals, LLC
Event
Event 93456
Status
Terminated
Classification
Class II
Quantity
1,122 syringes
Official record key
drug-enforcement:D-0413-2024

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 1223048138 exp 1/31/24

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility