Vivimed Life Sciences recalls Losartan Potassium three doses tablets, USP due traces of N-Nitroso-N-methyl-4-aminobutyric acid

CHENNAI, India–(BUSINESS WIRE)–Please replace the release dated May 3, 2019 with the following
corrected version due to multiple revisions in the first paragraph.

The corrected release reads:

VIVIMED LIFE SCIENCES Pvt Ltd ISSUES VOLUNTARY NATIONWIDE RECALL OF
LOSARTAN POTASSIUM 25 MG, 50 MG AND 100 MG TABLETS, USP DUE TO THE
DETECTION OF TRACE AMOUNTS OF N-Nitroso-N-methyl-4-aminobutyric acid
(NMBA) IMPURITY

Vivimed Life Sciences Pvt Ltd (Vivimed) is recalling 19 lots of Losartan
Potassium Tablets USP 25 mg, 50 mg, and 100 mg to consumer level due to
the detection of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), a
possible process impurity or contaminant in an active pharmaceutical
ingredient manufactured by Hetero Labs Limited (API manufacturer), 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 containing high levels of the impurity NMBA cannot be ruled out.

This product is made by Vivimed at its Plant in Alathur, Chennai, India
and Distributed by Heritage Pharmaceuticals Inc, East Brunswick
NJ (Heritage). To date, neither Vivimed nor Heritage has received any
reports of adverse events related to this recall.

Losartan Potassium is indicated for the treatment of hypertension,
hypertensive patients with left ventricular hypertrophy, nephropathy in
Type 2 diabetic patients and is packaged in 90-count and 1000-count
bottles. The lots were manufactured by Vivimed at its Plant in Alathur,
Chennai, India and Distributed by Heritage Pharmaceuticals Inc, East
Brunswick NJ (Heritage).

The identifying NDC #s associated with Heritage distributed
product are as follows:

Losartan Tablets 25 mg: 90- count: NDC 23155-644-09, Losartan Tablets 50
mg: 90- count: NDC 23155-645-09; 1000-count: NDC 23155-645-10, Losartan
Tablets 100 mg: 90-count- NDC 23155-646-09 1000-count: NDC 23155-646-10.

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

Inmar is notifying distributors and other customers by recall
notification and arranging for return of recalled product of Losartan
Potassium Tablets from the above lots.

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 from above
listed lots should stop using and dispensing the product immediately.
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.

Consumers with questions regarding this recall can contact Vivimed c/o
Inmar at 1-877-861-3811 Monday – Friday, 9am – 5pm EST.

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, online, by regular mail or by fax.

• • Complete and submit the report Online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

• • Regular Mail or Fax: Download form https://www.fda.gov/safety/medical-product-safety-information/medwatch-safety-alerts-human-medical-products
    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.