Macleods Pharma Usa Inc: Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, USP Rx Only, Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleo

Is my product affected?

Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, USP Rx Only, Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-052-10

• Brand LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Check against the official notice below — it lists the full affected range.

What happened

Macleods Pharma USA Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/25 mg in bottles of 90 tablets nationwide. The recall affects approximately 145,162 bottles containing 13,064,580 tablets due to the detection of an impurity called N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) in the active pharmaceutical ingredient used to manufacture the product. This represents a deviation from Current Good Manufacturing Practice (CGMP) standards.

The affected product was distributed nationwide and includes multiple lot codes manufactured between July 2019 and September 2021 (lot numbers BLM716A through BLM827A). The recall document provided does not specify what action consumers should take regarding this product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Details from the source

Reason for recall: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. Distribution: Nationwide Quantity: 145162 bottles (13,064,580 tablets) Lot/code info: BLM716A Jul-19 BLM717A Jul-19 BLM719A Aug-19 BLM720A Aug-19 BLM721A Sep-19 BLM722A Sep-19 BLM723A Oct-19 BLM724A Oct-19 BLM725A Oct-19 BLM726A Nov-19 BLM802A Dec-19 BLM803A Dec-19 BLM825A Sep-21 BLM826A Sep-21 BLM827A Sep-21

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-050-102019-06-20
• Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-count bottles (NDC# 68180-215-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.2022-03-31
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• Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-count bottles (NDC# 68180-216-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA2022-03-31
• Altaire Fluorescein Sodium with Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.25%/0.5%, 5 mL (Sterile), Rx only, Manufactured by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-205-052019-07-02

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