Reported Mar 27, 2019 · Ongoing

Losartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90), b) 500 count (NDC 31722-700-05) and c)…

Camber Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Camber Pharmaceuticals Inc · 1031 Centennial Ave · Piscataway, NJ · 08854-4125

Is this the product you have?

  • Losartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90), b) 500 count (NDC 31722-700-05) and c) 1000 count (NDC 31722-700-05) bottles
  • Manufactured forCamber Pharmaceuticals, Inc. Piscataway
  • NJ 08854 ByHetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India
Lot codes and dates

3 of 3 products

Products covered by this recall
#Product as published
1LOP17026B, LOP17050, LOP1705, LOP17052, LOP17053, Exp. Sep-19; LOP17061, Exp. Oct-19; LOP18035, LOP18036, Exp. Dec-19
2LOP17026, Exp. Sep-19
3LOP17006, Exp. May-19, LOP17025, Exp. Sep-19, LOP17068, Exp, Oct-19, LOP18037, LOP18038, LOP18039, Exp. Dec-19, LOP18057, Exp. Jan-20
Amount recalled
351,732 bottles

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 6:37 PM UTC

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