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Recall Observatory FDA recall evidence

Drug product

Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202 United States, Manufactured by: Lupin Limited, Manddeep, 462 046, India, NDC 68180-405-01

D-0390-2021

April 29, 2021

Class II

Product summary

Firm
Lupin Pharmaceuticals Inc.
Event
Event 87871
Status
Terminated
Classification
Class II
Quantity
3,138 bottles
Official record key
drug-enforcement:D-0390-2021

Official wording

Reason: Subpotent Drug

Code information: Lot #: F900787, Exp. Date 4/2021

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent