Legacy Pharmaceutical Packaging Recalls Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg

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 15, 2019

Contact

Consumer and Media Contact:

Consumers

Stericycle
 1-888-275-0506

Media

Legacy Pharmaceutical Packaging
 (314) 813-1555

Announcement

Earth City, MO, 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
68645-577-54	Losartan Potassium Tablets USP 25 mg	30	180952	10/2019
68645-577-54	Losartan Potassium Tablets USP 25 mg	30	180953	12/2019
68645-577-54	Losartan Potassium Tablets USP 25 mg	30	181086	09/2019
68645-577-54	Losartan Potassium Tablets USP 25 mg	30	181572	01/2020
68645-578-54	Losartan Potassium Tablets USP 50 mg	30	180921	09/2019
68645-578-54	Losartan Potassium Tablets USP 50 mg	30	180922	10/2019
68645-578-54	Losartan Potassium Tablets USP 50 mg	30	180923	11/2019
68645-578-54	Losartan Potassium Tablets USP 50 mg	30	180924	11/2019
68645-578-54	Losartan Potassium Tablets USP 50 mg	30	181118	11/2019
68645-578-54	Losartan Potassium Tablets USP 50 mg	30	181119	10/2019
68645-578-54	Losartan Potassium Tablets USP 50 mg	30	181407	11/2019
68645-578-54	Losartan Potassium Tablets USP 50 mg	30	181408	12/2019
68645-578-54	Losartan Potassium Tablets USP 50 mg	30	181573	02/2020
68645-578-54	Losartan Potassium Tablets USP 50 mg	30	181725	02/2020
68645-578-54	Losartan Potassium Tablets USP 50 mg	30	181726	02/2020
68645-578-54	Losartan Potassium Tablets USP 50 mg	30	181948	03/2020
68645-578-54	Losartan Potassium Tablets USP 50 mg	30	181960	02/2020
68645-578-54	Losartan Potassium Tablets USP 50 mg	30	182385	03/2020
68645-578-54	Losartan Potassium Tablets USP 50 mg	30	182386	03/2020
68645-578-54	Losartan Potassium Tablets USP 50 mg	30	182387	03/2020
68645-579-54	Losartan Potassium Tablets USP 100 mg	30	180886	11/2019
68645-579-54	Losartan Potassium Tablets USP 100 mg	30	180887	12/2019
68645-579-54	Losartan Potassium Tablets USP 100 mg	30	180888	12/2019
68645-579-54	Losartan Potassium Tablets USP 100 mg	30	180905	12/2019
68645-579-54	Losartan Potassium Tablets USP 100 mg	30	181123	09/2019
68645-579-54	Losartan Potassium Tablets USP 100 mg	30	181124	10/2019
68645-579-54	Losartan Potassium Tablets USP 100 mg	30	181125	08/2019
68645-579-54	Losartan Potassium Tablets USP 100 mg	30	181351	11/2019
68645-579-54	Losartan Potassium Tablets USP 100 mg	30	181352	12/2019
68645-579-54	Losartan Potassium Tablets USP 100 mg	30	181551	11/2019
68645-579-54	Losartan Potassium Tablets USP 100 mg	30	181628	06/2020
68645-579-54	Losartan Potassium Tablets USP 100 mg	30	181629	06/2020
68645-579-54	Losartan Potassium Tablets USP 100 mg	30	181727	06/2020
68645-579-54	Losartan Potassium Tablets USP 100 mg	30	181728	06/2020
68645-579-54	Losartan Potassium Tablets USP 100 mg	30	181890	03/2020
68645-579-54	Losartan Potassium Tablets USP 100 mg	30	181891	06/2020
68645-579-54	Losartan Potassium Tablets USP 100 mg	30	181897	06/2020
68645-579-54	Losartan Potassium Tablets USP 100 mg	30	182114	03/2020
68645-579-54	Losartan Potassium Tablets USP 100 mg	30	182119	06/2020
68645-579-54	Losartan Potassium Tablets USP 100 mg	30	182120	06/2020

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.

Consumers with questions regarding this recall can contact Stericycle at 1-888-275-0506, Monday – Friday, 9am – 5pm CST. 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.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332- 1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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

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