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Recall Observatory FDA recall evidence

Drug product

Estriol, USP (Micronized) 1 g, 5 g, 25 g, 100 g, 2000 g, 1 kg, containers, Packed by Medisca Inc., Plattsburgh, NY 12901, USA

D-0622-2020

November 25, 2019

Class II

Product summary

Firm
Medisca, Inc.
Event
Event 84357
Status
Terminated
Classification
Class II
Quantity
640,325 grams
Official record key
drug-enforcement:D-0622-2020

Official wording

Reason: Failed Impurities/Degradation Specifications

Code information: Lot #156110 A-P Lot #153328 A-D Lot #161726 A-L

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications