The Recall Desk
SevereFDA (Drugs)·D-1051-2019·Announced 2019-03-27

Preferred Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity

Preferred Pharmaceuticals is recalling Losartan Potassium 50 mg tablets because an impurity, N-Methylnitrosobutyric acid (NMBA), was identified.

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 agency classification is FDA Class II, and the presence of a nitrosamine impurity (NMBA) in a prescription drug represents a significant health risk, aligning with the 'Severe' criteria for significant injury reports or high-risk contamination.

Plain-English summary

Preferred Pharmaceuticals, Inc. is recalling Losartan Potassium Tablets, USP, 50 mg. The affected products are 30-count and 90-count bottles manufactured by Torrent Pharma Inc. and relabeled by Preferred Pharmaceuticals, Inc. The recall involves 530 units distributed in California, Georgia, and Indiana.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the presence of an impurity, N-Methylnitrosobutyric acid (NMBA), was identified in the product. The affected lots include 30-count bottles with lot codes C2218C (exp 9/2020) and D1318E (exp 10/2020), and 90-count bottles with lot codes C2719J (exp 9/2020) and E1818B (exp 10/2020).

Consumers who have these specific lot numbers should stop using the medication and contact their healthcare provider for guidance on alternative treatment options. The products are prescription-only (Rx Only).

The recalled product

Product
Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-03), b) 90-count bottle (NDC: 68788-0048-09), Rx Only, Mfg: Torrent Pharma Inc. Basking Ridge, NJ. Relabeled by: Preferred Pharmaceuticals, Inc. 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807.
Affected units
530

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 (9)

  • Count
  • lots
  • expiry: a) 30-count bottle C2218C
  • exp 9/2020
  • D1318E
  • exp 10/2020
  • b) 90-count bottle C2719J
  • E1818B
  • exp 10/2020.

Distribution

Distributed in 3 states: