RemedyRepack Recalls Losartan 50mg Tablets Due to Impurity
RemedyRepack Inc. is recalling Losartan 50mg tablets because trace amounts of an unexpected impurity, NMBA, were detected in the active ingredient.
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, which corresponds to a Severe rating under the rubric, particularly given the presence of a nitrosamine impurity in a pharmaceutical product.
Plain-English summary
RemedyRepack Inc. is recalling Losartan 50mg Tablets, 30 count each blister card. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations and the detection of trace amounts of an unexpected impurity, N-Methylnitrosobutyric acid (NMBA), in the active pharmaceutical ingredient (API).
The affected product consists of 33 blister cards containing 30 tablets each, totaling 990 tablets. The specific lot number is J0328416-101518, with an expiration date of 10/2019. The product code is 70518-0588-01.
The product was distributed to one sole customer located in Miami, FL. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance on replacement or further instructions.
The recalled product
- Product
- Losartan 50mg Tablet, 30 count each blister card.
- Manufacturer
- RemedyRepack Inc.
- Category
- Drug — Tablets
- Hazard
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 (3)
- 70518-0588-01
- Lot #: J0328416-101518
- Exp. Date: 10/2019
Distribution
Distribution scope not specified by the agency.
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