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Recall Observatory FDA recall evidence

Drug product

Phenylephrine HCL in 0.9% Sodium Chloride 10 mL, 1 mg/10 mL (100 mcg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-171-12

D-1074-2017

July 14, 2017

Class II

Product summary

Firm
Cantrell Drug Company
Event
Event 77780
Status
Terminated
Classification
Class II
Quantity
46078 syringes
Official record key
drug-enforcement:D-1074-2017

Official wording

Reason: Lack of Sterility Assurance.

Code information: Lot #: 9556, BUD: 7/26/2017; 9566, BUD: 7/30/2017; 9584, BUD; 8/1/2017; 9613, BUD: 8/6/2017; 9656, BUD: 8/14/2017; 9798, BUD: 9/11/2017; 9812, BUD: 8/31/2017; 9819, BUD: 9/16/2017; 9836, BUD: 9/17/2017; 9944, BUD: 10/3/2017; 10158, 10493, 10565, BUD: 10/30/2017

Distribution pattern: Nationwide within the US

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Sterility