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Recall Observatory FDA recall evidence

Drug product

Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only, (2 mg/mL), 100 mL Flexible Bag, Manufactured for: Claris LifeScience Inc. North Brunswick NJ 08902 by Claris Injectables Ltd. Gujarat, India UPC 336000008242 NDC 36000-008-249

D-0127-2018

November 06, 2017

Class III

Product summary

Firm
Claris Lifesciences Inc
Event
Event 78446
Status
Terminated
Classification
Class III
Quantity
Unavailable
Official record key
drug-enforcement:D-0127-2018

Official wording

Reason: Superpotent

Code information: A060192 01/2018; A060305 02/2018; A061038 08/2018; A0A0068 12/2018; A0A0404 04/2019

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Superpotent