Lupin Recalls Ethambutol Hydrochloride Tablets Due to Impurity
Lupin Pharmaceuticals is recalling 4,896 bottles of Ethambutol Hydrochloride 400 mg tablets because of an out-of-specification impurity result.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 agency classified this as an FDA Class III recall, which is defined as unlikely to cause adverse health consequences. The hazard is a chemical impurity without reported illness or injury, fitting the criteria for a moderate severity score.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling 4,896 bottles of Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles. The affected product is identified by Lot # 3122856 and has an expiration date of 05/14. The product is a prescription-only medication manufactured for Lupin Pharmaceuticals, Inc. in Baltimore, Maryland, and manufactured by Lupin Limited in Mumbai, India.
The recall was initiated due to a failed impurities/degradation specification, specifically an out-of-specification result for an impurity. The source text does not specify the identity of the impurity or the exact nature of the degradation.
The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or point of purchase for a refund or replacement, or disposed of according to local regulations.
The recalled product
- Product
- ETHAMBUTOL HYDROCHLORIDE (ETHAMBUTOL HYDROCHLORIDE)
- Brand
- ETHAMBUTOL HYDROCHLORIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 4,896
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 #: 3122856
- Exp 05/14
UPCs (3)
- 0368180281016
- 0368180280019
- 368180281016
Distribution
Distributed nationwide across the United States.
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