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Recall Observatory FDA recall evidence

Drug product

Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 500 mcg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

D-0590-2016

August 19, 2015

Class II

Product summary

Firm
Pharmakon Pharmaceuticals
Event
Event 72177
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0590-2016

Official wording

Reason: Stability data does not support expiry.

Code information: All lots with expiration dates up to 11/17/2015

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Stability data does not support expiry