Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA...
FDA Recall #D-0509-2025 — Class III — June 11, 2025
Product Description
Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharmaceuticals Ltd., Daman, India NDC# 33342-026-07.
Reason for Recall
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Recalling Firm
Macleods Pharmaceuticals Ltd — Mumbai, N/A
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
9,888/ 30 count bottles
Distribution
U.S. Nationwide.
Code Information
Lot # 12250247B, Exp. 01/31/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated