FDA Recall D-1153-2016

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

Atropine Sulfate Injection Solution, 0.4 mg/1 mL (0.4 mg/mL), in a) 1 mL syringes and b) 2 mL syringes, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-010-45, UPC: 0100352533010453

Lot / code: a) Lots: 149690, exp 9/14/15 and 151665, exp 11/5/15 and b) Lots: 149198, exp 9/3/15; 151454, exp 9/14/15; 151668, exp 11/5/15 and 151962, exp 11/11/15

Quantity: a) 450 syringes and b) 1250 syringes

Reason for recall

Subpotent Drug

Recall record

Recall number: D-1153-2016
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

‹ All recalls