March 2025 FDA Recall Drug by Medisca Inc.
D-0386-2025 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Medisca Inc. on March 31, 2025 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0386-2025

Reason for Recall
CGMP Deviations
Initiated
03-31-2025
Reported
04-30-2025
Quantity
161.6 grams

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96600
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Medisca Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-10-2025
Product Description About Product Description
Full technical description of the product.
Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06), c) 1g (NDC 38779-3066-09) drums, Medisca, Plattsburgh, NY

Batch or Lot Expiration Information

Lot# 201727/A/B/C/D/E & F, exp. date 05/31/2027, product # 3066
Lot# 208475/A/B/D/E/G/H & I, exp. date 09/30/2028, product # 3066