The Recall Desk
ModerateFDA (Drugs)·D-0663-2017·Announced 2017-04-19

Medisca Recalls Estriol USP Bulk Due to cGMP Deviations

Medisca, Inc. is recalling Estriol, USP (Micronized) Bulk in various bottle sizes due to cGMP deviations identified during an 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, which is generally remote or unlikely to cause serious adverse health consequences. The hazard is a manufacturing process deviation (cGMP) rather than a specific contamination or defect with reported injuries.

Plain-English summary

Medisca, Inc. has initiated a recall of Estriol, USP (Micronized) Bulk, packed in 5-gram, 25-gram, 100-gram, and 1-kilogram bottles. The recall was triggered by current Good Manufacturing Practice (cGMP) deviations and deficiencies noted during a recent FDA inspection.

The affected product is distributed nationwide as well as in Australia, the Bahamas, Italy, Singapore, Thailand, and the United Kingdom. Specific lot codes are listed in the recall documentation for each bottle size.

Consumers and healthcare providers should check their inventory for the specific NDC numbers and lot codes associated with this recall. If the product is found, it should be returned to the supplier or disposed of according to local regulations.

The recalled product

Product
ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams (NDC 38779-0732-04) , c) 100 grams (NDC 38779-0732-05), and d) 1 Kg (NDC 38779-0732-09) bottles, Packed by MEDISCA, INC. PLATTSBURGH, NY 12901; Product Code 0732
Manufacturer
Medisca, Inc.
Category
Drug — Active Pharmaceutical Ingredient (API)
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) 126317/D
  • 126317/F
  • 127288/C
  • 127296/D
  • 136212/C
  • 137155/C
  • 137156/C
  • 138638/C
  • 138646/B
  • 138646/E
  • 138646/I b) 126317/C
  • 126317/E
  • 127288/B
  • 127296/C
  • 136212/B
  • 137155/B
  • 137156/B
  • 138638/B
  • 138646/A
  • 138646/D

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 →

Related recalls

Same manufacturer · Medisca, Inc.

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Same hazard · cGMP deviation

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