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28-Feb-2019

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient (API)

PISCATAWAY, N.J., Feb. 28, 2019 /PRNewswire/ -- Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

NMBA is a potential human carcinogen. To date, Camber has not received any reports of adverse events related to this recall.  

Losartan Potassium, USP, is a prescription medication used to treat high blood pressure and congestive heart failure and is packaged in 30ct, 90ct, 500ct, 1000ct bottles. The identifying NDC #s associated with Camber's product as are follows: Losartan 25 mg 31722-700-90, 31722-700-05, 31722-700-10; Losartan 50 mg 31722-701-30, 31722-701-90, 31722-70-10; and Losartan 100 mg 31722-702-30, 31722-702-90, and 31722-702-10.

The affected Losartan includes 87 lot numbers which are listed below:

NDC

Name and Strength

Count

Lot#

Expiry

31722-700-90

Losartan Potassium Tablets USP 25 mg

90

LOP17026B

Sep-19

31722-700-90

Losartan Potassium Tablets USP 25 mg

90

LOP17050

Sep-19

31722-700-90

Losartan Potassium Tablets USP 25 mg

90

LOP17051

Sep-19

31722-700-90

Losartan Potassium Tablets USP 25 mg

90

LOP17052

Sep-19

31722-700-90

Losartan Potassium Tablets USP 25 mg

90

LOP17053

Sep-19

31722-700-90

Losartan Potassium Tablets USP 25 mg

90

LOP17061

Oct-19

31722-700-90

Losartan Potassium Tablets USP 25 mg

90

LOP18035

Dec-19

31722-700-90

Losartan Potassium Tablets USP 25 mg

90

LOP18036

Dec-19

31722-700-05

Losartan Potassium Tablets USP 25 mg

500

LOP17026

Sep-19

31722-700-10

Losartan Potassium Tablets USP 25 mg

1000

LOP17006

May-19

31722-700-10

Losartan Potassium Tablets USP 25 mg

1000

LOP17025

Sep-19

31722-700-10

Losartan Potassium Tablets USP 25 mg

1000

LOP17068

Oct-19

31722-700-10

Losartan Potassium Tablets USP 25 mg

1000

LOP18037

Dec-19

31722-700-10

Losartan Potassium Tablets USP 25 mg

1000

LOP18038

Dec-19

31722-700-10

Losartan Potassium Tablets USP 25 mg

1000

LOP18039

Dec-19

31722-700-10

Losartan Potassium Tablets USP 25 mg

1000

LOP18057

Jan-20

31722-701-30

Losartan Potassium Tablets USP 50 mg

30

LOP17028C

Sep-19

31722-701-30

Losartan Potassium Tablets USP 50 mg

30

LOP17064A

Nov-19

31722-701-90

Losartan Potassium Tablets USP 50 mg

90

LOP17027

Sep-19

31722-701-90

Losartan Potassium Tablets USP 50 mg

90

LOP17063

Nov-19

31722-701-90

Losartan Potassium Tablets USP 50 mg

90

LOP17093

Nov-19

31722-701-90

Losartan Potassium Tablets USP 50 mg

90

LOP17094

Dec-19

31722-701-90

Losartan Potassium Tablets USP 50 mg

90

LOP17095

Dec-19

31722-701-90

Losartan Potassium Tablets USP 50 mg

90

LOP17097A

Dec-19

31722-701-90

Losartan Potassium Tablets USP 50 mg

90

LOP17105

Dec-19

31722-701-90

Losartan Potassium Tablets USP 50 mg

90

LOP17107

Dec-19

31722-701-10

Losartan Potassium Tablets USP 50 mg

1000

LOP17004

Dec-19

31722-701-10

Losartan Potassium Tablets USP 50 mg

1000

LOP17028B

Sep-19

31722-701-10

Losartan Potassium Tablets USP 50 mg

1000

LOP17048

Oct-19

31722-701-10

Losartan Potassium Tablets USP 50 mg

1000

LOP17049

Oct-19

31722-701-10

Losartan Potassium Tablets USP 50 mg

1000

LOP17056

Nov-19

31722-701-10

Losartan Potassium Tablets USP 50 mg

1000

LOP17073

Nov-19

31722-701-10

Losartan Potassium Tablets USP 50 mg

1000

LOP17074

Nov-19

31722-701-10

Losartan Potassium Tablets USP 50 mg

1000

LOP17076

Nov-19

31722-701-10

Losartan Potassium Tablets USP 50 mg

1000

LOP17096

Dec-19

31722-701-10

Losartan Potassium Tablets USP 50 mg

1000

LOP18077A

Feb-20

31722-701-10

Losartan Potassium Tablets USP 50 mg

1000

LOP18078

Feb-20

31722-701-10

Losartan Potassium Tablets USP 50 mg

1000

LOP18079

Feb-20

31722-701-10

Losartan Potassium Tablets USP 50 mg

1000

LOP18080

Feb-20

31722-701-10

Losartan Potassium Tablets USP 50 mg

1000

LOP18081

Mar-20

31722-701-10

Losartan Potassium Tablets USP 50 mg

1000

LOP18084

Mar-20

31722-701-10

Losartan Potassium Tablets USP 50 mg

1000

LOP18095

Mar-20

31722-701-10

Losartan Potassium Tablets USP 50 mg

1000

LOP18096

Mar-20

31722-702-30

Losartan Potassium Tablets USP 100 mg

30

LOP17011

Aug-19

31722-702-30

Losartan Potassium Tablets USP 100 mg

30

LOP17087

Nov-19

31722-702-90

Losartan Potassium Tablets USP 100 mg

90

LOP17012

Aug-19

31722-702-90

Losartan Potassium Tablets USP 100 mg

90

LOP17013

Aug-19

31722-702-90

Losartan Potassium Tablets USP 100 mg

90

LOP17042

Oct-19

31722-702-90

Losartan Potassium Tablets USP 100 mg

90

LOP17043

Oct-19

31722-702-90

Losartan Potassium Tablets USP 100 mg

90

LOP17044

Nov-19

31722-702-90

Losartan Potassium Tablets USP 100 mg

90

LOP17045

Nov-19

31722-702-90

Losartan Potassium Tablets USP 100 mg

90

LOP18024

Dec-19

31722-702-90

Losartan Potassium Tablets USP 100 mg

90

LOP18025

Dec-19

31722-702-90

Losartan Potassium Tablets USP 100 mg

90

LOP18026

Dec-19

31722-702-90

Losartan Potassium Tablets USP 100 mg

90

LOP18027

Dec-19

31722-702-90

Losartan Potassium Tablets USP 100 mg

90

LOP18028

Dec-19

31722-702-90

Losartan Potassium Tablets USP 100 mg

90

LOP18029

Dec-19

31722-702-90

Losartan Potassium Tablets USP 100 mg

90

LOP18030

Dec-19

31722-702-10

Losartan Potassium Tablets USP 100 mg

1000

LOP17005

May-19

31722-702-10

Losartan Potassium Tablets USP 100 mg

1000

LOP17014

Aug-19

31722-702-10

Losartan Potassium Tablets USP 100 mg

1000

LOP17016

Sep-19

31722-702-10

Losartan Potassium Tablets USP 100 mg

1000

LOP17023

Sep-19

31722-702-10

Losartan Potassium Tablets USP 100 mg

1000

LOP17083

Oct-19

31722-702-10

Losartan Potassium Tablets USP 100 mg

1000

LOP17084

Nov-19

31722-702-10

Losartan Potassium Tablets USP 100 mg

1000

LOP17085

Nov-19

31722-702-10

Losartan Potassium Tablets USP 100 mg

1000

LOP17086

Nov-19

31722-702-10

Losartan Potassium Tablets USP 100 mg

1000

LOP18021

Dec-19

31722-702-10

Losartan Potassium Tablets USP 100 mg

1000

LOP18022

Dec-19

31722-702-10

Losartan Potassium Tablets USP 100 mg

1000

LOP18023

Dec-19

31722-702-10

Losartan Potassium Tablets USP 100 mg

1000

LOP18031

Dec-19

31722-702-10

Losartan Potassium Tablets USP 100 mg

1000

LOP18032

Dec-19

31722-702-10

Losartan Potassium Tablets USP 100 mg

1000

LOP18033

Dec-19

31722-702-10

Losartan Potassium Tablets USP 100 mg

1000

LOP18050

Dec-19

31722-702-10

Losartan Potassium Tablets USP 100 mg

1000

LOP18051

Dec-19

31722-702-10

Losartan Potassium Tablets USP 100 mg

1000

LOP18109

Mar-20

31722-702-10

Losartan Potassium Tablets USP 100 mg

1000

LOP18111

Mar-20

31722-702-10

Losartan Potassium Tablets USP 100 mg

1000

LOP18122

Jun-20

31722-702-10

Losartan Potassium Tablets USP 100 mg

1000

LOP18123

Jun-20

31722-702-10

Losartan Potassium Tablets USP 100 mg

1000

LOP18124

Jun-20

31722-702-10

Losartan Potassium Tablets USP 100 mg

1000

LOP18125

Jun-20

31722-702-10

Losartan Potassium Tablets USP 100 mg

1000

LOP18126

Jun-20

31722-702-10

Losartan Potassium Tablets USP 100 mg

1000

LOP18127

Jun-20

31722-702-10

Losartan Potassium Tablets USP 100 mg

1000

LOP18128

Jun-20

31722-702-10

Losartan Potassium Tablets USP 100 mg

1000

LOP18129

Jun-20

31722-702-10

Losartan Potassium Tablets USP 100 mg

1000

LOP18130

Jun-20

31722-702-10

Losartan Potassium Tablets USP 100 mg

1000

LOP18131C

Jun-20

31722-702-10

Losartan Potassium Tablets USP 100 mg

1000

LOP18133

Jun-20

Losartan Potassium Tablets were distributed Nationwide to Wholesalers, Distributors, Retail Pharmacies, and Mail Order Pharmacies.

Stericycle is notifying Camber's distributors and other customers by recall letter and arranging for return of recalled product of Losartan Potassium Tablets.

Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking the product. Pharmacies and healthcare facilities that have the product being recalled should stop using and dispensing the product immediately.

Consumers with questions regarding this recall can contact Camber Pharmaceuticals' Med Line at 1-866-495-1995 Monday – Friday, 9am – 5pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug administration.

View original content:http://www.prnewswire.com/news-releases/camber-pharmaceuticals-inc-issues-voluntary-nationwide-recall-of-losartan-potassium-tablets-usp-25-mg-50-mg-and-100-mg-due-to-the-detection-of-trace-amounts-of-n-nitroso-n-methyl-4-amino-butyric-acid-nmba-impurity-found-in--300804323.html

SOURCE Camber Pharmaceuticals

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Last Updated: 28-Feb-2019