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Recall Observatory FDA recall evidence

Drug product

Succinylcholine Chloride 200 mg/10 mL Injection Solution 10 mL (20 mg/mL) ,Single-Dose Syringe Injection Solution, For Slow IV Use Only ,Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207, NDC 52533-067-12

D-0204-2017

November 18, 2016

Class II

Product summary

Firm
Cantrell Drug Company
Event
Event 75745
Status
Terminated
Classification
Class II
Quantity
9859 syringes
Official record key
drug-enforcement:D-0204-2017

Official wording

Reason: Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

Code information: Lot: 169262 BUD: 1/8/2017, Lot: 169812 BUD: 1/19/2017

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility