Famciclovir Tablets Recalled Due to Temperature Abuse During Distribution
Hetero Labs Limited is recalling 8,436 bottles of Famciclovir 500 mg tablets because high temperatures during distribution caused the tablets to become wet, stuck together, and disintegrated.
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: The recall is classified as FDA Class II, and the hazard involves physical degradation of the drug product due to temperature abuse without reports of serious injury or death, fitting the criteria for a moderate severity recall.
Plain-English summary
Hetero Labs Limited Unit V is recalling 8,436 bottles of Famciclovir Tablets, 500 mg, 30-count bottles. The product is manufactured for Camber Pharmaceuticals, Inc. and is identified by Lot # FMC17039 with an expiration date of 07/2019. The recall is classified as FDA Class II.
The recall was initiated due to temperature abuse during distribution. Complaints indicated that the tablets were wet and stuck together, with the tablet coating peeled and disintegrated as a result of prolonged exposure to high temperatures. The affected product was distributed nationwide in the USA.
Consumers who have this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for guidance on replacement or disposal. The recall is limited to the specific lot number and expiration date listed above.
The recalled product
- Product
- FAMCICLOVIR (FAMCICLOVIR)
- Brand
- FAMCICLOVIR
- Manufacturer
- Hetero Labs Limited Unit V
- Category
- Drug — Prescription Medication
- Affected units
- 8,436
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 # FMC17039
- Exp 07/2019.
Distribution
Distributed nationwide across the United States.
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