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Recall Observatory FDA recall evidence

Drug product

Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India, NDC 6818-0659-06

D-0437-2024

March 21, 2024

Class II

Product summary

Firm
Lupin Pharmaceuticals Inc.
Event
Event 94271
Status
Terminated
Classification
Class II
Quantity
26,352 bottles
Official record key
drug-enforcement:D-0437-2024

Official wording

Reason: Subpotent Drug

Code information: Lot #: A201064, Exp. Date March 2024

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent