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Recall Observatory FDA recall evidence

Drug product

Midazolam HCl in 0.9% Sodium Chloride Injection, 0.5 mg/mL 1 mL (0.5 mg/mL), 1 mL syringes, Rx Only, Cantrell Drug Co., Little Rock AR --- NDC 52533-157-45, UPC: 0100352533157455

D-1162-2016

August 21, 2015

Class II

Product summary

Firm
Cantrell Drug Company
Event
Event 72028
Status
Terminated
Classification
Class II
Quantity
3853 syringes
Official record key
drug-enforcement:D-1162-2016

Official wording

Reason: Subpotent Drug

Code information: Lot: 6218, exp 9/17/15; 6877, exp 1/24/16

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent