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Recall Observatory FDA recall evidence

Drug product

Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-658-06

D-0283-2024

January 05, 2024

Class II

Product summary

Firm
Lupin Pharmaceuticals Inc.
Event
Event 93753
Status
Terminated
Classification
Class II
Quantity
15,576 Bottles
Official record key
drug-enforcement:D-0283-2024

Official wording

Reason: Subpotent Drug and Failed Impurities/Degradation Specifications

Code information: A200816 exp 1/2024 A201248 exp 3/2024

Distribution pattern: Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent