FDA Drugs recall ·
Bimatoprost powder, Bulk Ingredient, a) 5g ( recall
- Recall number
- D-0386-2025
- Date
- (initiated March 31, 2025)
- Company / brand
- Medisca Inc.
6641 N Belt Line Rd Ste 130, Irving, TX, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Terminated
- Units affected
- 161.6 grams
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
CGMP Deviations
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
US Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0386-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.