FDA-Drug2025-07-16Class III

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.

Macleods Pharmaceuticals Ltd
Hazard

Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.

Sold states
U.S. Nationwide.
Affected count
9,888/ 30 count bottles
Manufactured in
304 Atlanta Arcade, Church Road, Mumbai, N/A, India
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0509-2025

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