Class III
Ongoing
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.
This recall is currently active, issued July 16, 2025. It was issued by Macleods Pharmaceuticals Ltd.
- Company
- Macleods Pharmaceuticals Ltd
- Recall Initiated
- June 11, 2025
- Posted
- July 16, 2025
- Recall Number
- D-0509-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 9,888/ 30 count bottles
- Firm Location
- Mumbai, India
- Official Source
- View on FDA website ↗
Reason for Recall
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Distribution
U.S. Nationwide.
Lot / Code Info
Lot # 12250247B, Exp. 01/31/2027
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