Reported Mar 27, 2019 · Ongoing

Losartan Potassium Tablets USP, 50 mg, Rx only, a) 30 count (NDC 31722-701-30), b) 90 count (NDC 31722-701-90), c) 1000…

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
- 50 mg
- Rx only
- a) 30 count (NDC 31722-701-30)
- b) 90 count (NDC 31722-701-90)
- c) 1000 count (NDC 31722-701-10) 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 LOP17028C, Exp. Sep-19, LOP17064A, Exp. Nov-19
2 LOP17027, Exp Sep-19, LOP17063, LOP17093, Exp. Nov-19; LOP17094, LOP17095, LOP17097A, LOP17105, LOP17107, Exp. Dec-19
3 LOP17004, Exp Dec-19, LOP17028B, Exp Sep-19, LOP17048, LOP17049 Exp Oct-19, LOP17056, LOP17073, LOP17074, LOP17076 Exp Nov-19, LOP17096, Exp Dec-19, LOP18077A, LOP18078, LOP18079, LOP18080 Exp Feb-20; LOP18081, LOP18084, LOP18095, LOP18096 Exp Mar-20
Amount recalled: 69712 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	LOP17028C, Exp. Sep-19, LOP17064A, Exp. Nov-19
2	LOP17027, Exp Sep-19, LOP17063, LOP17093, Exp. Nov-19; LOP17094, LOP17095, LOP17097A, LOP17105, LOP17107, Exp. Dec-19
3	LOP17004, Exp Dec-19, LOP17028B, Exp Sep-19, LOP17048, LOP17049 Exp Oct-19, LOP17056, LOP17073, LOP17074, LOP17076 Exp Nov-19, LOP17096, Exp Dec-19, LOP18077A, LOP18078, LOP18079, LOP18080 Exp Feb-20; LOP18081, LOP18084, LOP18095, LOP18096 Exp Mar-20