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Recall Observatory FDA recall evidence

Drug product

MIDAZOLAM HCl in 0.9% Sodium Chloride Injection, 2 mg/2 mL (1 mg/mL), in 2 mL syringe, Rx only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-001-16 UPC: 0100352533001161

D-1164-2016

August 21, 2015

Class II

Product summary

Firm
Cantrell Drug Company
Event
Event 72028
Status
Terminated
Classification
Class II
Quantity
1570 syringes
Official record key
drug-enforcement:D-1164-2016

Official wording

Reason: Subpotent Drug

Code information: Lot: 6178, exp, 9/12/15; 6529, exp 11/22/15

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent