Recalling firm
Macleods Pharmaceuticals Ltd
Product type
Drug
Status
Ongoing
Report date
2025-07-16
Distribution
U.S. Nationwide.
Firm state
N/A
Product quantity
9,888/ 30 count bottles
Initiated by
Voluntary: Firm initiated
Reason for recall
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
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.
Code / lot info
Lot # 12250247B, Exp. 01/31/2027
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.