The Recall Desk
SevereFDA (Drugs)·D-1043-2019·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 impurity (NMBA) in a prescription drug, which meets the rubric criteria for a Severe rating due to the potential for significant health risks associated with nitrosamines.

Plain-English summary

Camber Pharmaceuticals Inc. is recalling Losartan Potassium Tablets USP, 100 mg, in 30, 90, and 1000-count bottles. The recall involves 683,641 bottles distributed nationwide. The product was manufactured by Hetero Hetero Labs Limited in India for Camber Pharmaceuticals, Inc.

The recall was initiated 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 agency has classified this recall as Class II.

Consumers should check their medication for the specific lot numbers and expiration dates listed in the official recall notice. If the medication matches the recalled lots, patients should contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
Brand
LOSARTAN POTASSIUM
Manufacturer
Camber Pharmaceuticals Inc
Category
Drug — Prescription Drug
Hazard
Affected units
683,641

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) LOP17011
  • Exp Aug-19
  • Lot LOP17087 Exp Nov-19
  • b) LOP17012
  • LOP17013
  • LOP17042
  • LOP17043 Exp Oct-19
  • LOP17044
  • LOP17045
  • Exp Nov-19
  • LOP18024
  • LOP18025
  • LOP18026
  • LOP18027
  • LOP18028
  • LOP18029
  • LOP18030
  • Exp. Dec-19
  • c) LOP17005
  • Exp May-19

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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