The Recall Desk
ModerateFDA (Drugs)·D-0666-2017·Announced 2017-04-19

Medisca Recalls Estradiol Bulk Due to cGMP Deviations

Medisca, Inc. is recalling Estradiol, USP Bulk (Hemihydrate) in 25 g and 100 g bottles 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 and is a voluntary precautionary recall initiated by the manufacturer due to cGMP deviations. No illnesses or injuries are reported, and the product is a bulk API not directly consumed by patients.

Plain-English summary

Medisca, Inc. is voluntarily recalling Estradiol, USP Bulk (Hemihydrate) in 25 g (NDC 38779-2261-04) and 100 g (NDC 38779-2261-05) bottles. The recall was initiated by the manufacturer after deficiencies were noted during a recent FDA inspection, resulting in Current Good Manufacturing Practice (cGMP) deviations.

The affected product is packed by Medisca, Inc. in Plattsburgh, NY, under Product Code 2261. Specific lot codes are listed in the recall documentation, including 129669/C, 129669/F, 129669/H, 129669/J, 130941/B, 130941/D, 130941/F, 136108/B, 139091/B for the 25 g bottles, and 129669/B, 129669/E, 130941/A, 130941/C, 130941/E, 130941/G, 136108/A for the 100 g bottles.

The product was distributed nationwide and internationally to Australia, the Bahamas, Italy, Singapore, Thailand, and the United Kingdom. As this is a bulk API product, it is intended for use by pharmaceutical manufacturers rather than direct consumers. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product
ESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100 g (NDC 38779-2261-05) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY Product Code 2261
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 (15)

  • a) 129669/C
  • 129669/F
  • 129669/H
  • 129669/J
  • 130941/B 130941/D
  • 130941/F
  • 136108/B
  • 139091/B
  • b) 129669/B
  • 129669/E
  • 130941/A
  • 130941/C
  • 130941/E
  • 130941/G
  • 136108/A

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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