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Recall Observatory FDA recall evidence

Drug product

Ascorbic Acid 400 MG/ML (Non-Corn) Injection Solution, 65 mL per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0914-65

D-1635-2019

June 19, 2019

Class II

Product summary

Firm
RXQ Compounding LLC
Event
Event 83074
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-1635-2019

Official wording

Reason: Crystallization

Code information: All lots within expiry

Distribution pattern: Nationwide USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Crystallization