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Recall Observatory FDA recall evidence

Drug product

Succinylcholine Chloride, 100 mg per 5mL, 20 mg per mL syringe. IV Use Only. JCB Laboratories, 8710 E 34th St., N. Wichita, KS 67226 UPC 7335968405

D-0946-2017

June 19, 2017

Class II

Product summary

Firm
Fagron Compounding Services LLC dba Fagron Sterile Services
Event
Event 77584
Status
Terminated
Classification
Class II
Quantity
1,056 5mL syringes
Official record key
drug-enforcement:D-0946-2017

Official wording

Reason: Lack Of Assurance Of Sterility: voluntary recall initiated by the commercial supplier

Code information: Lot #: C274-000000331, BUD 08/30/2017; C274-000001274, BUD 09/07/2017; C274-000001326, BUD 09/14/2017

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack Of Assurance Of Sterility