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Recall Observatory FDA recall evidence

Drug product

Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (Racepinephrine 11.25 mg) 10 individual foil wrapped vials with 1 EZ Breathe Atomizer per carton, Manufactured By: nephron pharmaceuticals corporation, Orlando, FL --- NDC 0487-2784-10

D-0388-2016

August 21, 2015

Class II

Product summary

Firm
Nephron Pharmaceuticals Corp.
Event
Event 72102
Status
Terminated
Classification
Class II
Quantity
47,754 cartons
Official record key
drug-enforcement:D-0388-2016

Official wording

Reason: Discoloration

Code information: Lots R4027A (Exp 10/31/2015), R4036A (Exp 12/31/2015)

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Discoloration