Hetero USA Recalls Entecavir Tablets Due to Impurity Specification Failure
Hetero USA Inc. is recalling 5,664 bottles of Entecavir 0.5 mg tablets because a single unknown impurity exceeded the allowed limit during stability testing.
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 source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Hetero USA Inc. is recalling 5,664 bottles of Entecavir Tablets 0.5 mg, 30 tablets per container. The product is manufactured for Camber Pharmaceuticals, Inc. and distributed in New Jersey. The specific lot affected is # ENT17008 with an expiration date of 01/2019.
The recall was initiated because the product failed an impurities/degradation specification. Testing at the three-month stability point revealed a single unknown impurity at 0.33%, which exceeds the established limit of not more than 0.20% weight/weight.
Consumers who have this specific lot of Entecavir should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ENTECAVIR (ENTECAVIR)
- Brand
- ENTECAVIR
- Manufacturer
- Hetero USA Inc
- Category
- Drug — Antiviral
- Hazard
- Affected units
- 5,664
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 # ENT17008
- Exp 01/2019
Distribution
Distributed in 1 state:
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