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Recall Observatory FDA recall evidence

Drug product

Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count bottle, NDC 68001-501-00; (b) 500-count bottle, NDC 68001-501-03. Manufactured by Alkem Laboratories Ltd., India. For BluePoint Laboratories

D-0269-2023

January 11, 2023

Class II

Product summary

Firm
Amerisource Health Services LLC
Event
Event 91528
Status
Terminated
Classification
Class II
Quantity
(a) 6670 100-count (b) 2666 500-count bottles
Official record key
drug-enforcement:D-0269-2023

Official wording

Reason: Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.

Code information: Lots: (a) 21143211, EXP 03/31/2023; (b) 21143185, 21143193, EXP 02/28/2023

Distribution pattern: Nationwide USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Dissolution Specifications