FDA Drug Recalls

Recalls / Class II

Class IID-0386-2025

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

Affected lot / code info
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

Why it was recalled

CGMP Deviations

Recalling firm

Firm
Medisca Inc.
Notification channel
N/A
Type
Voluntary: Firm initiated
Address
6641 N Belt Line Rd Ste 130, N/A, Irving, Texas 75063-6001

Distribution

Quantity
161.6 grams
Distribution pattern
US Nationwide.

Timeline

Recall initiated
2025-03-31
FDA classified
2025-04-21
Posted by FDA
2025-04-30
Terminated
2025-10-10
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0386-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls