Lupin Recalls Quinapril Tablets Due to Impurity A Specification Failure
Lupin Pharmaceuticals is recalling Quinapril 5 mg tablets because they failed impurity specifications. The recall covers 15,168 bottles distributed nationwide.
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 recall is classified as FDA Class III, which indicates a low probability of adverse health consequences. The hazard is a specification failure (Impurity A) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Lupin Pharmaceuticals, Inc. is recalling Quinapril Tablets USP 5 mg, 90 count bottles (NDC 68180-556-09). The recall is due to the product failing impurities/degradation specifications, specifically regarding Impurity A.
The affected product is identified by Batch number G303703 with an expiration date of 3/2016. A total of 15,168 bottles were distributed nationwide.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on replacement or alternative treatment.
The recalled product
- Product
- QUINAPRIL (QUINAPRIL)
- Brand
- QUINAPRIL
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 15,168
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)
- Batch number G303703
- exp 3/2016
UPCs (2)
- 0368180559092
- 0368180556091
Distribution
Distributed nationwide across the United States.
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