June 2019

Macleods Pharmaceutical Limited Issues Voluntary Nationwide Consumer Level Recall of Losartan Potassium 50mg and Losartan Potassium/Hydrochlorothiazide combination Tablets

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.

Teva Pharmaceuticals USA, Inc. Expands Voluntary Nationwide Recall of Losartan Potassium

Teva Pharmaceuticals USA, Inc. has expanded its voluntary consumer-level recall originally initiated on April 25, 2019 in the United States of losartan potassium tablets. This expanded recall includes six (6) lots of bulk losartan potassium USP Tablets (two lots of 50 mg strength and four lots of 100 mg strength) due to the detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – that is above the US Food & Drug Administration’s interim acceptable exposure limit of 9.82 ppm. The source of the NMBA impurity was detected in one lot of active pharmaceutical ingredient (API), manufactured by Hetero Labs Limited, which was used in the manufacturing of the six (6) bulk lots of these drug products. Based on the available information, there is a potential risk of developing cancer in a few patients following long-term use of products containing high levels of NMBA.

Heritage Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Amikacin Sulfate Injection

Heritage Pharmaceuticals Inc. (“Heritage”) East Brunswick, New Jersey, is initiating a voluntary recall of Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL), Lot: VEAC025, Expiry Date: October 2019 and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL), Lot: VPCA172, Expiry Date: April 2020, to the consumer level. These drug products are manufactured by Emcure Pharmaceuticals Ltd. (“Emcure”) and distributed by Heritage. The voluntary recall is being initiated due to microbial growth having been detected in one unreleased sublot of Lot VPCA172 and one unreleased sublot Lot VEAC025, which may indicate a lack of sterility in the other sublots.