FDA Recall D-1156-2016

Cantrell Drug Company · Little Rock, AR

Class I — life-threatening Terminated 532 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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

Lot / code: 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

Quantity: a) 564 syringes and b) 1146 syringes

Reason for recall

Subpotent Drug

Recall record

Recall number: D-1156-2016
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide
Recall initiated: 2015-08-21
Classified by FDA Center: 2016-07-06
FDA published: 2016-07-13
Terminated: 2017-02-03
Recalling firm: Cantrell Drug Company
Firm location: Little Rock, AR

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