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Recall Observatory FDA recall evidence

Drug product

Ephedrine Sulfate in 0.9% Sodium Chloride 10 mL, 50 mg/10 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-019-12

D-1061-2017

July 14, 2017

Class II

Product summary

Firm
Cantrell Drug Company
Event
Event 77780
Status
Terminated
Classification
Class II
Quantity
24638 syringes
Official record key
drug-enforcement:D-1061-2017

Official wording

Reason: Lack of Sterility Assurance.

Code information: Lot #: 9906, 9915 BUD: 7/28/2017; 9950, 9984, 10001,10010, BUD: 8/4/2017; 10064, BUD: 8/17/2017; 10341, 10452 BUD: 9/23/2017,

Distribution pattern: Nationwide within the US

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Sterility