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Recall Observatory FDA recall evidence

Drug product

fentaNYL citrate in 0.9% Sodium Chloride Injection, 5 mcg/1 mL (5 mcg/mL), in a) 1 mL syringe (NDC 52533-214-45, UPC: 0100352533214455) and b) 3 mL syringe (NDC 52533-214-60, UPC: 0100352533214608), Rx Only, Cantrell Drug Co., Little Rock, AR

D-1156-2016

August 21, 2015

Class I

Product summary

Firm
Cantrell Drug Company
Event
Event 72028
Status
Terminated
Classification
Class I
Quantity
a) 564 syringes and b) 1146 syringes
Official record key
drug-enforcement:D-1156-2016

Official wording

Reason: Subpotent Drug

Code information: a) Lots: 148292, exp 11/9/15 and 150610, exp 1/6/16 and b) Lots: 6208, exp 9/16/15 and 6851, exp 1/19/16

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent