The Recall Desk
SevereFDA (Drugs)·D-1041-2019·Announced 2019-03-27

Camber Pharmaceuticals Recalls Losartan Potassium Tablets Due to NMBA Contamination

Camber Pharmaceuticals is recalling Losartan Potassium tablets because trace amounts of the nitrosamine 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 and involves the detection of a nitrosamine (NMBA), a known carcinogen, in a prescription medication, which aligns with the 'Severe' criteria for significant health risks.

Plain-English summary

Camber Pharmaceuticals, Inc. is recalling Losartan Potassium Tablets USP, 25 mg, in 90, 500, and 1000-count bottles. The recall is due to Current Good Manufacturing Practice (CGMP) deviations and the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) in the active pharmaceutical ingredient.

The affected products were distributed nationwide. The recall includes specific lot numbers and expiration dates ranging from May 2019 to January 2020. The total quantity involved is 351,732 bottles.

Consumers should stop using the recalled medication and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The FDA has classified this recall as Class II, indicating a reasonable probability that temporary or medically reversible adverse health consequences could occur.

The recalled product

Product
LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
Brand
LOSARTAN POTASSIUM
Manufacturer
Camber Pharmaceuticals Inc
Category
Drug — Prescription Medication
Hazard
Affected units
351,732

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 (20)

  • a) LOP17026B
  • LOP17050
  • LOP1705
  • LOP17052
  • LOP17053
  • Exp. Sep-19
  • LOP17061
  • Exp. Oct-19
  • LOP18035
  • LOP18036
  • Exp. Dec-19
  • b) LOP17026
  • c) LOP17006
  • Exp. May-19
  • LOP17025
  • LOP17068
  • Exp
  • Oct-19
  • LOP18037
  • LOP18038

UPCs (3)

  • 0331722702300
  • 0331722700900
  • 0331722701303

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Camber Pharmaceuticals Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same brand · LOSARTAN POTASSIUM

Same manufacturer · Camber Pharmaceuticals Inc

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Same hazard · nitrosamine contamination

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