The Recall Desk
SevereFDA (Drugs)·D-0622-2020·Announced 2019-12-25

Medisca Recalls Estriol USP Micronized Due to Failed Impurity Specifications

Medisca, Inc. is recalling specific lots of Estriol, USP (Micronized) because the product failed impurities and degradation specifications.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the failure of impurity and degradation specifications for a pharmaceutical product.

Plain-English summary

Medisca, Inc. is recalling specific lots of Estriol, USP (Micronized) in various container sizes (1 g, 5 g, 25 g, 100 g, 2000 g, and 1 kg). The recall is being conducted because the product failed impurities and degradation specifications. The affected lots are #156110 A-P, #153328 A-D, and #161726 A-L.

The recall covers a total of 640,325 grams of the product, which was distributed nationwide. The product was packed by Medisca, Inc. in Plattsburgh, NY.

Consumers and healthcare providers should check their inventory for the specific lot numbers listed above. If you have these products, you should stop using them and contact Medisca, Inc. or your supplier for instructions on how to return or dispose of the recalled items.

The recalled product

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
Manufacturer
Medisca, Inc.
Category
Drug — Pharmaceutical Ingredient
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot #156110 A-P Lot #153328 A-D Lot #161726 A-L

Distribution

Distributed nationwide across the United States.

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