D-0386-2025 Class II Terminated
FDA drug recall D-0386-2025 was initiated by Medisca Inc. on March 31, 2025 and is designated Class II. Reason for recall: CGMP Deviations The recall status is terminated (terminated October 10, 2025). Affected quantity: 161.6 grams.
Recall Details
- Product Type
- Drugs
- Report Date
- April 30, 2025
- Initiation Date
- March 31, 2025
- Termination Date
- October 10, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 161.6 grams
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
Distribution Pattern
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