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Recall Observatory FDA recall evidence

Drug product

Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920 NDC 13668-462-01

D-0166-2021

November 25, 2020

Class I

Product summary

Firm
Torrent Pharma Inc
Event
Event 86878
Status
Terminated
Classification
Class I
Quantity
2496 Bottles
Official record key
drug-enforcement:D-0166-2021

Official wording

Reason: Failed Dissolution Specifications

Code information: Batch BFD1G001, exp 12/2021

Distribution pattern: Nationwide USA and Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Dissolution Specifications