Reported Mar 27, 2019 · Ongoing

Losartan Potassium Tablets USP, 100 mg, Rx only, a) 30 count (NDC 31722-702-30), b) 90 count (NDC 31722-702-30), 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

- Losartan Potassium Tablets USP
- 100 mg
- Rx only
- a) 30 count (NDC 31722-702-30)
- b) 90 count (NDC 31722-702-30)
- c) 1000 count (NDC 31722-702-10) 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
1 LOP17011, Exp Aug-19, Lot LOP17087 Exp Nov-19
2 LOP17012, LOP17013, Exp Aug-19, LOP17042, LOP17043 Exp Oct-19, LOP17044, LOP17045, Exp Nov-19, LOP18024, LOP18025, LOP18026, LOP18027, LOP18028, LOP18029, LOP18030, Exp. Dec-19
3 LOP17005, Exp May-19, LOP17014, Exp Aug-19, LOP17016, LOP17023, Exp Sep-19, LOP17083, Exp Oct-19, LOP17084, LOP17085, LOP17086, Exp Nov-19, LOP18021, LOP18022, LOP18023, LOP18031, LOP18032, LOP18033, LOP18050, LOP18051, Exp Dec-19, LOP18109, LOP18111, Exp Mar-20, LOP18122, LOP18123, LOP18124, LOP18125, LOP18126, LOP18127, LOP18128, LOP18129, LOP18130, LOP18131C, LOP18133, Exp Jun-20
Amount recalled: 683,641 bottles

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

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.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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#	Product as published
1	LOP17011, Exp Aug-19, Lot LOP17087 Exp Nov-19
2	LOP17012, LOP17013, Exp Aug-19, LOP17042, LOP17043 Exp Oct-19, LOP17044, LOP17045, Exp Nov-19, LOP18024, LOP18025, LOP18026, LOP18027, LOP18028, LOP18029, LOP18030, Exp. Dec-19
3	LOP17005, Exp May-19, LOP17014, Exp Aug-19, LOP17016, LOP17023, Exp Sep-19, LOP17083, Exp Oct-19, LOP17084, LOP17085, LOP17086, Exp Nov-19, LOP18021, LOP18022, LOP18023, LOP18031, LOP18032, LOP18033, LOP18050, LOP18051, Exp Dec-19, LOP18109, LOP18111, Exp Mar-20, LOP18122, LOP18123, LOP18124, LOP18125, LOP18126, LOP18127, LOP18128, LOP18129, LOP18130, LOP18131C, LOP18133, Exp Jun-20