Famciclovir tablets recalled after a hair was found on a tablet
Famciclovir Tablets USP 500 mg from Macleods Pharma are being recalled because a black hair strand was found attached to a tablet in a sealed bottle. 9,888 bottles are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall for a single foreign substance finding with no health consequence stated in the source.
Plain-English summary
Famciclovir Tablets, USP 500 mg, 30-count bottles, prescription only, manufactured for Macleods Pharma USA, Inc. by Macleods Pharmaceuticals Ltd. of Daman, India, NDC 33342-026-07, are being recalled. The action covers 9,888 30-count bottles.
The stated reason is the presence of a foreign substance: a black hair strand was found attached to a tablet in a sealed bottle. The FDA classified the action as Class III, its least serious classification.
The affected lot is 12250247B, expiring 01/31/2027. Distribution was nationwide in the United States.
Patients holding the affected lot should speak to their pharmacist before stopping treatment, and pharmacies should follow the instructions issued by the manufacturer.
The recalled product
- Product
- FAMCICLOVIR (FAMCICLOVIR)
- Brand
- FAMCICLOVIR
- Manufacturer
- Macleods Pharmaceuticals Ltd
- Category
- Drug — Oral tablet
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 12250247B
- Exp. 01/31/2027
UPCs (3)
- 0333342026071
- 0333342024077
- 0333342025074
Distribution
Distributed nationwide across the United States.
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