The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0664-2017·Announced 2017-04-19

Medisca Recalls Estrone USP Bulk Due to cGMP Deviations

Medisca, Inc. is recalling Estrone, USP Bulk in various bottle sizes due to current Good Manufacturing Practice (cGMP) deviations identified during an FDA inspection.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall corresponds to a score of 4 (Severe), particularly when associated with manufacturing deficiencies that could impact product quality.

Plain-English summary

Medisca, Inc. has initiated a recall of Estrone, USP Bulk, a pharmaceutical active ingredient (API) product. The recall covers bottles of 100 mgs, 1 gram, 5 grams, 25 grams, and 100 grams, packed by Medisca, Inc. in Plattsburgh, NY. The product is identified by NDC numbers 38779-0891-05, 38779-0891-06, 38779-0891-03, 38779-0891-04, and 38779-0891-09, and Product Code 0891.

The recall was initiated by the manufacturer after deficiencies were noted during a recent FDA inspection. These deficiencies are described as cGMP (current Good Manufacturing Practice) deviations. The FDA has classified this recall as Class II, which indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The affected product was distributed nationwide as well as in Australia, the Bahamas, Italy, Singapore, Thailand, and the United Kingdom. Specific lot codes are listed in the source data for each bottle size. Consumers and healthcare providers should check their inventory for these specific NDC numbers and lot codes. If the product is found, it should be returned to the supplier or the recalling firm, Medisca, Inc.

The recalled product

Product
ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-0891-06), c) 5 grams (NDC 38779-0891-03), d) 25 grams (NDC 38779-0891-04), and e) 100 grams (NDC 38779-0891-09) Bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0891
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) 124880/D
  • 124880/O
  • 130940/J
  • 124880/H
  • 124880/M
  • 130940/C
  • 130940/H
  • 135312/C
  • 135312/H
  • 136546/C d) 124880/A
  • 130940/B
  • 130940/G
  • 135312/B
  • 135312/G
  • 136546/B
  • 139489/A e) 124880/G
  • 124880/J
  • 124880/L
  • 130940/A
  • 130940/F

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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