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Recall Observatory FDA recall evidence

Drug product

HEParin Sodium 0.5 USP UNITS/mL in 0.225% SODIUM CHLORIDE, in 3 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992212

D-1159-2016

August 21, 2015

Class II

Product summary

Firm
Cantrell Drug Company
Event
Event 72028
Status
Terminated
Classification
Class II
Quantity
352 syringes
Official record key
drug-enforcement:D-1159-2016

Official wording

Reason: Stability Data Does Not Support Expiry

Code information: Lot: 150090, exp 12/24/15

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Stability Data Does Not Support Expiry