Safety

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Losartan Potassium Tablets USP, 25 mg. 90 Tablets

Losartan Potassium Tablets USP, 25 mg. 500 Tablets

Losartan Potassium Tablets USP, 25 mg. 1000 Tablets

Losartan Potassium Tablets USP, 50 mg. 30 Tablets

Losartan Potassium Tablets USP, 50 mg. 90 Tablets

Losartan Potassium Tablets USP, 50 mg. 1000 Tablets

Losartan Potassium Tablets USP, 100 mg. 30 Tablets

Losartan Potassium Tablets USP, 100 mg. 90 Tablets

Losartan Potassium Tablets USP, 100 mg. 1000 Tablets

Announcement

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:

NDCName and StrengthCountLot#Expiry
31722-700-90Losartan Potassium Tablets USP 25 mg90LOP17026BSep-19
31722-700-90Losartan Potassium Tablets USP 25 mg90LOP17050Sep-19
31722-700-90Losartan Potassium Tablets USP 25 mg90LOP17051Sep-19
31722-700-90Losartan Potassium Tablets USP 25 mg90LOP17052Sep-19
31722-700-90Losartan Potassium Tablets USP 25 mg90LOP17053Sep-19
31722-700-90Losartan Potassium Tablets USP 25 mg90LOP17061Oct-19
31722-700-90Losartan Potassium Tablets USP 25 mg90LOP18035Dec-19
31722-700-90Losartan Potassium Tablets USP 25 mg90LOP18036Dec-19
31722-700-05Losartan Potassium Tablets USP 25 mg500LOP17026Sep-19
31722-700-10Losartan Potassium Tablets USP 25 mg1000LOP17006May-19
31722-700-10Losartan Potassium Tablets USP 25 mg1000LOP17025Sep-19
31722-700-10Losartan Potassium Tablets USP 25 mg1000LOP17068Oct-19
31722-700-10Losartan Potassium Tablets USP 25 mg1000LOP18037Dec-19
31722-700-10Losartan Potassium Tablets USP 25 mg1000LOP18038Dec-19
31722-700-10Losartan Potassium Tablets USP 25 mg1000LOP18039Dec-19
31722-700-10Losartan Potassium Tablets USP 25 mg1000LOP18057Jan-20
31722-701-30Losartan Potassium Tablets USP 50 mg30LOP17028CSep-19
31722-701-30Losartan Potassium Tablets USP 50 mg30LOP17064ANov-19
31722-701-90Losartan Potassium Tablets USP 50 mg90LOP17027Sep-19
31722-701-90Losartan Potassium Tablets USP 50 mg90LOP17063Nov-19
31722-701-90Losartan Potassium Tablets USP 50 mg90LOP17093Nov-19
31722-701-90Losartan Potassium Tablets USP 50 mg90LOP17094Dec-19
31722-701-90Losartan Potassium Tablets USP 50 mg90LOP17095Dec-19
31722-701-90Losartan Potassium Tablets USP 50 mg90LOP17097ADec-19
31722-701-90Losartan Potassium Tablets USP 50 mg90LOP17105Dec-19
31722-701-90Losartan Potassium Tablets USP 50 mg90LOP17107Dec-19
31722-701-10Losartan Potassium Tablets USP 50 mg1000LOP17004Dec-19
31722-701-10Losartan Potassium Tablets USP 50 mg1000LOP17028BSep-19
31722-701-10Losartan Potassium Tablets USP 50 mg1000LOP17048Oct-19
31722-701-10Losartan Potassium Tablets USP 50 mg1000LOP17049Oct-19
31722-701-10Losartan Potassium Tablets USP 50 mg1000LOP17056Nov-19
31722-701-10Losartan Potassium Tablets USP 50 mg1000LOP17073Nov-19
31722-701-10Losartan Potassium Tablets USP 50 mg1000LOP17074Nov-19
31722-701-10Losartan Potassium Tablets USP 50 mg1000LOP17076Nov-19
31722-701-10Losartan Potassium Tablets USP 50 mg1000LOP17096Dec-19
31722-701-10Losartan Potassium Tablets USP 50 mg1000LOP18077AFeb-20
31722-701-10Losartan Potassium Tablets USP 50 mg1000LOP18078Feb-20
31722-701-10Losartan Potassium Tablets USP 50 mg1000LOP18079Feb-20
31722-701-10Losartan Potassium Tablets USP 50 mg1000LOP18080Feb-20
31722-701-10Losartan Potassium Tablets USP 50 mg1000LOP18081Mar-20
31722-701-10Losartan Potassium Tablets USP 50 mg1000LOP18084Mar-20
31722-701-10Losartan Potassium Tablets USP 50 mg1000LOP18095Mar-20
31722-701-10Losartan Potassium Tablets USP 50 mg1000LOP18096Mar-20
31722-702-30Losartan Potassium Tablets USP 100 mg30LOP17011Aug-19
31722-702-30Losartan Potassium Tablets USP 100 mg30LOP17087Nov-19
31722-702-90Losartan Potassium Tablets USP 100 mg90LOP17012Aug-19
31722-702-90Losartan Potassium Tablets USP 100 mg90LOP17013Aug-19
31722-702-90Losartan Potassium Tablets USP 100 mg90LOP17042Oct-19
31722-702-90Losartan Potassium Tablets USP 100 mg90LOP17043Oct-19
31722-702-90Losartan Potassium Tablets USP 100 mg90LOP17044Nov-19
31722-702-90Losartan Potassium Tablets USP 100 mg90LOP17045Nov-19
31722-702-90Losartan Potassium Tablets USP 100 mg90LOP18024Dec-19
31722-702-90Losartan Potassium Tablets USP 100 mg90LOP18025Dec-19
31722-702-90Losartan Potassium Tablets USP 100 mg90LOP18026Dec-19
31722-702-90Losartan Potassium Tablets USP 100 mg90LOP18027Dec-19
31722-702-90Losartan Potassium Tablets USP 100 mg90LOP18028Dec-19
31722-702-90Losartan Potassium Tablets USP 100 mg90LOP18029Dec-19
31722-702-90Losartan Potassium Tablets USP 100 mg90LOP18030Dec-19
31722-702-10Losartan Potassium Tablets USP 100 mg1000LOP17005May-19
31722-702-10Losartan Potassium Tablets USP 100 mg1000LOP17014Aug-19
31722-702-10Losartan Potassium Tablets USP 100 mg1000LOP17016Sep-19
31722-702-10Losartan Potassium Tablets USP 100 mg1000LOP17023Sep-19
31722-702-10Losartan Potassium Tablets USP 100 mg1000LOP17083Oct-19
31722-702-10Losartan Potassium Tablets USP 100 mg1000LOP17084Nov-19
31722-702-10Losartan Potassium Tablets USP 100 mg1000LOP17085Nov-19
31722-702-10Losartan Potassium Tablets USP 100 mg1000LOP17086Nov-19
31722-702-10Losartan Potassium Tablets USP 100 mg1000LOP18021Dec-19
31722-702-10Losartan Potassium Tablets USP 100 mg1000LOP18022Dec-19
31722-702-10Losartan Potassium Tablets USP 100 mg1000LOP18023Dec-19
31722-702-10Losartan Potassium Tablets USP 100 mg1000LOP18031Dec-19
31722-702-10Losartan Potassium Tablets USP 100 mg1000LOP18032Dec-19
31722-702-10Losartan Potassium Tablets USP 100 mg1000LOP18033Dec-19
31722-702-10Losartan Potassium Tablets USP 100 mg1000LOP18050Dec-19
31722-702-10Losartan Potassium Tablets USP 100 mg1000LOP18051Dec-19
31722-702-10Losartan Potassium Tablets USP 100 mg1000LOP18109Mar-20
31722-702-10Losartan Potassium Tablets USP 100 mg1000LOP18111Mar-20
31722-702-10Losartan Potassium Tablets USP 100 mg1000LOP18122Jun-20
31722-702-10Losartan Potassium Tablets USP 100 mg1000LOP18123Jun-20
31722-702-10Losartan Potassium Tablets USP 100 mg1000LOP18124Jun-20
31722-702-10Losartan Potassium Tablets USP 100 mg1000LOP18125Jun-20
31722-702-10Losartan Potassium Tablets USP 100 mg1000LOP18126Jun-20
31722-702-10Losartan Potassium Tablets USP 100 mg1000LOP18127Jun-20
31722-702-10Losartan Potassium Tablets USP 100 mg1000LOP18128Jun-20
31722-702-10Losartan Potassium Tablets USP 100 mg1000LOP18129Jun-20
31722-702-10Losartan Potassium Tablets USP 100 mg1000LOP18130Jun-20
31722-702-10Losartan Potassium Tablets USP 100 mg1000LOP18131CJun-20
31722-702-10Losartan Potassium Tablets USP 100 mg1000LOP18133Jun-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 reactions or quality problems associated with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

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

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