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Recall Observatory FDA recall evidence

Drug product

Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-118-15

D-1064-2017

July 14, 2017

Class II

Product summary

Firm
Cantrell Drug Company
Event
Event 77780
Status
Terminated
Classification
Class II
Quantity
49666 syringes
Official record key
drug-enforcement:D-1064-2017

Official wording

Reason: Lack of Sterility Assurance.

Code information: Lot #: 9904, 9914, 9939, BUD: 7/28/2017; 9952, 9969, 10004, BUD: 8/4/2017; 10043, 10088, 10115, BUD: 8/17/2017; 10269, BUD: 9/8/2017;10431, BUD: 9/23/2017; 10554, BUD: 10/27/2017

Distribution pattern: Nationwide within the US

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Sterility