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Recall Observatory FDA recall evidence

Drug product

Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 India, NDC 68180-721-03

D-0899-2023

June 27, 2023

Class III

Product summary

Firm
Lupin Pharmaceuticals Inc.
Event
Event 92618
Status
Terminated
Classification
Class III
Quantity
3,096 bottles
Official record key
drug-enforcement:D-0899-2023

Official wording

Reason: Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.

Code information: Lot #: A102887, Exp. 6/2023

Distribution pattern: Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent