The Recall Desk
ModerateFDA (Drugs)·D-0665-2017·Announced 2017-04-19

Medisca Recalls Estradiol API Due to cGMP Deviations

Medisca, Inc. is recalling Estradiol, USP (Hemihydrate) (Micronized) API products due to cGMP deviations identified during a recent FDA inspection.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and is a voluntary precautionary recall initiated by the manufacturer following cGMP deviations, with no reported illnesses or injuries.

Plain-English summary

Medisca, Inc. has initiated a recall of Estradiol, USP (Hemihydrate) (Micronized) active pharmaceutical ingredient (API) products in various bottle sizes, ranging from 100 mg to 1 kg. The recall was triggered by deficiencies noted during a recent FDA inspection, which resulted in Current Good Manufacturing Practice (cGMP) deviations.

The affected products are distributed nationwide as well as in Australia, the Bahamas, Italy, Singapore, Thailand, and the United Kingdom. The recall covers multiple NDC codes and lot numbers associated with the Estradiol API.

Consumers and healthcare providers should stop using the affected products and contact Medisca, Inc. or their healthcare provider for further instructions on returns or replacements.

The recalled product

Product
ESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b) 1 g (NDC 38779-0869-06), c) 5 g (NDC 38779-0869-03), d) 10 g (NDC 38779-0869-01), e) 25 g (NDC 38779-0869-04), f) 100 g (NDC 38779-0869-05) , g) 500 g (NDC 38779-0869-08), h) 1 Kg (NDC 38779-0869-09)
Manufacturer
Medisca, Inc.
Category
Drug — Active 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 (20)

  • a) 137169/F b) 129670/G
  • 129670/K
  • 130942/G
  • 130942/L
  • 131429/G
  • 131430/G
  • 137169/E c) 129670/F
  • 129670/J
  • 130942/F
  • 130942/K 131429/F
  • 131430/F
  • 137169/D
  • d) 129670/E
  • 129670/I
  • 130942/E
  • 130942/J
  • 131429/E
  • 131430/E
  • 137169/C e) 129670/D
  • 129670/H

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Medisca, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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