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Recall Observatory FDA recall evidence

Drug product

SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-09, Bar Code 70004090809

D-0424-2024

November 09, 2023

Class II

Product summary

Firm
SCA Pharmaceuticals, LLC
Event
Event 93456
Status
Terminated
Classification
Class II
Quantity
5,079 syringe
Official record key
drug-enforcement:D-0424-2024

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #:1223049085 Exp 11/29/23; 1223049364 Exp 12/12/23

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility