Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06), c) 1g ...

FDA Recall #D-0386-2025 — Class II — March 31, 2025

Recall #D-0386-2025 Date: March 31, 2025 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

CGMP Deviations

Recalling Firm

Medisca Inc. — Irving, TX

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

161.6 grams

Distribution

US Nationwide.

Code 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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated