Safety

Company Announcement

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Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg 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)

For Immediate Release

March 25, 2019

Contact

Consumers

Dispensing Pharmacy

Media

Legacy Pharmaceutical Packaging
314-813-1555
 

 

Announcement

Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. This recall was prompted due to Camber Pharmaceuticals, Inc. issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, 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, (API manufacturer).

NMBA is a potential human carcinogen. To date, Legacy 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 bottles. The identifying NDC numbers associated with Legacy’s product are as follows:

               Losartan Potassium, USP, 25mg                   NDC 68645-577-54
               Losartan Potassium, USP, 50mg                   NDC 68645-578-54
               Losartan Potassium, USP, 100mg                 NDC 68645-579-54

The affected Losartan Potassium includes 40 repackaged lots numbers which are listed below:

LEGACY NDC# Name and Strength Count Legacy Lot # Expiry
68645-577-54Losartan Potassium Tablets USP 25 mg3018095210/2019
68645-577-54Losartan Potassium Tablets USP 25 mg3018095312/2019
68645-577-54Losartan Potassium Tablets USP 25 mg3018108609/2019
68645-577-54Losartan Potassium Tablets USP 25 mg3018157201/2020
68645-578-54Losartan Potassium Tablets USP 50 mg3018092109/2019
68645-578-54Losartan Potassium Tablets USP 50 mg3018092210/2019
68645-578-54Losartan Potassium Tablets USP 50 mg3018092311/2019
68645-578-54Losartan Potassium Tablets USP 50 mg3018092411/2019
68645-578-54Losartan Potassium Tablets USP 50 mg3018111811/2019
68645-578-54Losartan Potassium Tablets USP 50 mg3018111910/2019
68645-578-54Losartan Potassium Tablets USP 50 mg3018140711/2019
68645-578-54Losartan Potassium Tablets USP 50 mg3018140812/2019
68645-578-54Losartan Potassium Tablets USP 50 mg3018157302/2020
68645-578-54Losartan Potassium Tablets USP 50 mg3018172502/2020
68645-578-54Losartan Potassium Tablets USP 50 mg3018172602/2020
68645-578-54Losartan Potassium Tablets USP 50 mg3018194803/2020
68645-578-54Losartan Potassium Tablets USP 50 mg3018196002/2020
68645-578-54Losartan Potassium Tablets USP 50 mg3018238503/2020
68645-578-54Losartan Potassium Tablets USP 50 mg3018238603/2020
68645-578-54Losartan Potassium Tablets USP 50 mg3018238703/2020
68645-579-54Losartan Potassium Tablets USP 100 mg3018088611/2019
68645-579-54Losartan Potassium Tablets USP 100 mg3018088712/2019
68645-579-54Losartan Potassium Tablets USP 100 mg3018088812/2019
68645-579-54Losartan Potassium Tablets USP 100 mg3018090512/2019
68645-579-54Losartan Potassium Tablets USP 100 mg3018112309/2019
68645-579-54Losartan Potassium Tablets USP 100 mg3018112410/2019
68645-579-54Losartan Potassium Tablets USP 100 mg3018112508/2019
68645-579-54Losartan Potassium Tablets USP 100 mg3018135111/2019
68645-579-54Losartan Potassium Tablets USP 100 mg3018135212/2019
68645-579-54Losartan Potassium Tablets USP 100 mg3018155111/2019
68645-579-54Losartan Potassium Tablets USP 100 mg3018162806/2020
68645-579-54Losartan Potassium Tablets USP 100 mg3018162906/2020
68645-579-54Losartan Potassium Tablets USP 100 mg3018172706/2020
68645-579-54Losartan Potassium Tablets USP 100 mg3018172806/2020
68645-579-54Losartan Potassium Tablets USP 100 mg3018189003/2020
68645-579-54Losartan Potassium Tablets USP 100 mg3018189106/2020
68645-579-54Losartan Potassium Tablets USP 100 mg3018189706/2020
68645-579-54Losartan Potassium Tablets USP 100 mg3018211403/2020
68645-579-54Losartan Potassium Tablets USP 100 mg3018211906/2020
68645-579-54Losartan Potassium Tablets USP 100 mg3018212006/2020

The product can be identified by checking the product name and repackaged lot number on the bottle containing these products.

Losartan Potassium was distributed by pharmacies nationwide. Legacy Pharmaceutical Packaging LLC is notifying its distributors and customers in writing and is arranging/assisting for return of all recalled products to (a) For Distribution Center Level, please return the products to Legacy Pharmaceutical Packaging LLC; (b) For Retail Level, please return the products to Genco; or (c) For Consumer Level, please return the products to the dispensing pharmacy, whichever is applicable. Instructions for returning recalled products are provided in the recall letter.

If you have any medical questions regarding this recall, please contact Camber Pharmaceuticals, Inc. at 1-866-495-1995 (8:00 am – 4:30 pm Eastern Time).

Consumers with questions regarding this recall can contact your dispensing pharmacy during normal business hours. 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 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

###

Product Photos

  • •	Losartan Potassium Tablet USP 25 mg, product label 
  • Losartan Potassium Tablet USP 25 mg, product label 
  • Losartan Potassium Tablet USP 50 mg, product label 
  • Losartan Potassium Tablet USP 50 mg, tablet image 
  • Losartan Potassium Tablet USP 100 mg, product label 
  • Losartan Potassium Tablet USP 100 mg, tablet image 

Page Last Updated: 03/28/2019
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