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Recall Observatory FDA recall evidence

Drug product

Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride 10 mL syringes, PharMEDium Services, LLC 913 N Davis Ave Cleveland, MS, NDC 71019-263-20

D-0221-2018

September 26, 2017

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 78695
Status
Terminated
Classification
Class II
Quantity
2390 syringes
Official record key
drug-enforcement:D-0221-2018

Official wording

Reason: Superpotent Drug

Code information: Lot #: 172560019M, Exp. 12/13/2017

Distribution pattern: Nationwide within the US

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Superpotent

Field note

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