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Recall Observatory FDA recall evidence

Drug product

HEPARIN Sodium in 0.45% Sodium Chloride, 1 USP Unit/2 mL (0.5 USP Units/mL), Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-148-16, UPC: 0100352533148163

D-1160-2016

August 21, 2015

Class II

Product summary

Firm
Cantrell Drug Company
Event
Event 72028
Status
Terminated
Classification
Class II
Quantity
4170 syringes
Official record key
drug-enforcement:D-1160-2016

Official wording

Reason: Stability Data Does Not Support Expiry

Code information: Lot: 6146, exp 9/5/15

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Stability Data Does Not Support Expiry