The Recall Desk
SevereFDA (Drugs)·D-1081-2019·Announced 2019-04-17

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.

What this means for you

Illness, injury, or structural failure has been reported. 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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