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Recall Observatory FDA recall evidence

Drug product

Succinylcholine Chloride Injection Solution 5 mL, 100 mg/5 mL (20 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-067-15

D-1069-2017

July 14, 2017

Class II

Product summary

Firm
Cantrell Drug Company
Event
Event 77780
Status
Terminated
Classification
Class II
Quantity
18015 syringes
Official record key
drug-enforcement:D-1069-2017

Official wording

Reason: Lack of Sterility Assurance.

Code information: Lot #: 10076, BUD: 7/24/2017; 10106, BUD: 7/27/2017; 10145, BUD: 8/2/2017; 10220, BUD: 8/13/2017; 10298, BUD: 8/20/2017; 10400, BUD: 9/6/2017; 10446, BUD: 9/14/2017; 10548, BUD: 9/27/2017

Distribution pattern: Nationwide within the US

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Sterility