Lupin Recalls Lisinopril Tablets Due to Metal Contaminant
Lupin Pharmaceuticals is recalling specific lots of Lisinopril tablets because a metal contaminant was found in one tablet.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving potential physical hazards like foreign substances in medication.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling 11,706 bottles of Lisinopril Tablets USP, 10mg, 1000-count bottles. The affected product is identified by Lot # H800414 and has an expiration date of 12/2019. The NDC for the recalled product is 68180-980-03.
The recall was initiated after a product complaint was received reporting the presence of a metal contaminant in one tablet. This is classified as an FDA Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The product was distributed to distributors, mail order pharmacies, and supermarkets throughout the United States. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If found, the product should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- LISINOPRIL (LISINOPRIL)
- Brand
- LISINOPRIL
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 11,706
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 #: H800414
- Exp. 12/2019
UPCs (3)
- 0368180513018
- 0368180512028
- 0368180513032
Distribution
Distribution scope not specified by the agency.
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