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Recall Observatory FDA recall evidence

Drug product

Sodium Bicarbonate 8.4% Injection Solution 50 mL, 50 mEq (1mEq/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222

D-1075-2017

July 14, 2017

Class II

Product summary

Firm
Cantrell Drug Company
Event
Event 77780
Status
Terminated
Classification
Class II
Quantity
40081 syringes
Official record key
drug-enforcement:D-1075-2017

Official wording

Reason: Lack of Sterility Assurance.

Code information: Lot#: 10349, BUD: 7/30/2017; 10356, BUD: 7/31/2017; 10377, BUD: 8/4/2017; 10386, BUD: 8/5/2017; 10394, BUD: 8/6/2017; 10404, BUD: 8/8/2017; 10423 BUD: 8/12/2017; 10468, BUD: 8/18/2017; 10473, BUD: 8/19/2017; 10482, BUD: 8/20/2017; 10514, BUD: 8/25/2017; 10524, BUD: 8/26/2017; 10569, BUD: 9/3/2017

Distribution pattern: Nationwide within the US

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Sterility