Drug recall D-0509-2025

Class III Ongoing reported Jul 16, 2025

Product

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.

Lots and codes

Lot # 12250247B, Exp. 01/31/2027

Recall details

Recalling firm
Macleods Pharmaceuticals Ltd, Mumbai, N/A
Quantity
9,888/ 30 count bottles
Distribution
U.S. Nationwide.
Type
Voluntary: Firm initiated
Recall initiated
June 11, 2025

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