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Recall Observatory FDA recall evidence

Drug 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

D-1153-2016

August 21, 2015

Class I

Product summary

Firm
Cantrell Drug Company
Event
Event 72028
Status
Terminated
Classification
Class I
Quantity
a) 450 syringes and b) 1250 syringes
Official record key
drug-enforcement:D-1153-2016

Official wording

Reason: Subpotent Drug

Code information: 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

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent