Macleods Pharmaceutical Limited Issues Voluntary Nationwide Consumer Level Recall of Losartan Potassium 50mg and Losartan Potassium/Hydrochlorothiazide combination Tablets 50mg/12.5mg, 100mg/12.5mg and 100mg/25mg due to detection of NMBA (N-Nitroso-N­ Methyl-4-aminobutyric acid) Impurity.

COMPANY ANNOUNCEMENT

Summary

• Company Announcement Date: June 25, 2019
• FDA Publish Date: June 26, 2019
• Product Type: Drugs
• Reason for Announcement: Presence of NMBA impurity
• Company Name: Macleods Pharmaceutical Limited
• Brand Name: Macleods
• Product Description: Losartan Potassium USP tablets and Losartan Potassium/Hydrochlorothiazide combination tablets

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Company Announcement

Macleods Pharmaceuticals Limited has initiated a voluntary recall in the United States, to the patient level, of 32 lots of Losartan Potassium USP Tablets (2 lots of 50mg strength) and Losartan Potassium/Hydrochlorothiazide combination Tablets (12 lots  of  50mg/12.5mg strength, 3 lots of 100mg/12.5mg strength and 15 100mg/25mg strength) to the patient level due to the detection of trace amounts of an unexpected impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). The impurity was found in 32 lots of active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited that is above the US Food & Drug Administration's interim acceptable exposure limit of 9.82 ppm. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out.

Losartan Potassium Tablets and Losartan Potassium/Hydrochlorothiazide combination Tablets are indicated to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy. Patients who are on Losartan Potassium Tablets and Losartan Potassium/Hydrochlorothiazide combination Tablets, USP should continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment.

To date, Macleods Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

The products subject to recall are listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

Losartan Potassium Tablets 50 mg
NDC	Manufacturer	Product Description	Lot/Batch	Expiration Date
33342-045-10	Macleods Pharmaceuticals Limited	Losartan Potassium.Tablets USP 50mg 90ct	BLl711A	Nov-19
33342-045-44	Macleods Pharmaceuticals Limited	Losartan Potassium Tablets USP 50mg 1000ct	BLl710A	Nov-19
Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mg
NDC	Manufacturer	Product Description	Lot/Batch	Expiration Date
33342-050-10	Macleods Pharmaceuticals Limited	Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mg	BLK719A	Sep-19
33342-050-10	Macleods Pharmaceuticals Limited	Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mg	BLK720A	Sep-19
33342-050-10	Macleods Pharmaceuticals Limited	Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mg	BLK721A	Sep-19
33342-050-10	Macleods Pharmaceuticals Limited	Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mg	BLK722A	Sep-19
33342-050-10	Macleods Pharmaceuticals Limited	Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mg	BLK723A	Sep-19
33342-050-10	Macleods Pharmaceuticals Limited	Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mg	BLK724A	Sep-19
33342-050-10	Macleods Pharmaceuticals Limited	Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mg	BLK725A	Oct-19
33342-050-10	Macleods Pharmaceuticals Limited	Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mg	BLK726A	Oct-19
33342-050-10	Macleods Pharmaceuticals Limited	Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mg	BLK804A	Jan-20
33342-050-10	Macleods Pharmaceuticals Limited	Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mg	BLK806A	Jan-20
33342-050-10	Macleods Pharmaceuticals Limited	Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mg	BLK825A	Oct-21
33342-050-10	Macleods Pharmaceuticals Limited	Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mg	BLK826A	Oct-21
Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 12.5 mg
NDC	Manufacturer	Product Description	Lot/Batch	Expiration Date
33342-051-10	Macleods Pharmaceuticals Limited	Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 12.5 mg	BLL801A	Dec-19
33342-051-10	Macleods Pharmaceuticals Limited	Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 12.5 mg	BLL802A	Dec-19
33342-051-10	Macleods Pharmaceuticals Limited	Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 12.5 mg	BLL803A	Dec-19
Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg
NDC	Manufacturer	Product Description	Lot/Batch	Expiration Date
33342-052-10	Macleods Pharmaceuticals Limited	Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg	BLM716A	Jul-19
33342-052-10	Macleods Pharmaceuticals Limited	Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg	BLM717A	Jul-19
33342-052-10	Macleods Pharmaceuticals Limited	Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg	BLM719A	Aug-19
33342-052-10	Macleods Pharmaceuticals Limited	Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg	BLM720A	Aug-19
33342-052-10	Macleods Pharmaceuticals Limited	Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg	BLM721A	Sep-19
33342-052-10	Macleods Pharmaceuticals Limited	Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg	BLM722A	Sep-19
33342-052-10	Macleods Pharmaceuticals Limited	Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg	BLM723A	Oct-19
33342-052-10	Macleods Pharmaceutica Is Limited	Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg	BLM724A	Oct-19
33342-052-10	Macleods Pharmaceutical Limited	Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg	BLM725A	Oct-19
33342-052-10	Macleods Pharmaceuticals Limited	Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg	BLM726A	Nov-19
33342-052-10	Macleods Pharmaceuticals Limited	Losartan Potassium and Hydrochlorothiazide Tablets 100 mg I 25 mg	BLM802A	Dec-19
33342-052-10	Macleods Pharmaceutical Limited	Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg	BLM803A	Dec-19
33342-052-10	Macleods Pharmaceuticals Limited	Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg	BLM825A	Sep-21
33342-052-10	Macleods Pharmaceuticals Limited	Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg	BLM826A	Sep-21
33342-052-10	Macleods Pharmaceuticals Limited	Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg	BLM827A	Sep-21

Losartan Potassium Tablets 50mg and Losartan Potassium/Hydrochlorothiazide combination Tablets 50mg/12.5mg, 100mg/25mg and 100mg/12.5mg  were distributed nationwide to Macleods wholesale distributor and retail customers. Macleods Pharmaceuticals Limited is notifying its distributors and customers by phone and/or in writing to immediately discontinue distribution of the specific lot being recalled and to notify their sub-accounts. Macleods is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products  are given in the recall letter.

Consumers with medical questions regarding this recall or to report an adverse event can contact Macleods Pharmaceuticals Limited at 855-926-3384 (8:00 am - 5:00 pm EST).

If you have any general questions regarding the return of this product, please contact Qualanex via email at recall@qualanex .com or call 888-280-2046 (7:00 am to 4:00 pm CST Monday to Friday).

Consumers should also 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
• Regular Mail or Fax: Download form 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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Company Contact Information

• Consumers: Macleods Pharmaceuticals Limited ; 855-926-3384

• Media: K.R. Jayaram ; +91 2261132900

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