May 2024 FDA Recall Losartan Potassium And Hydrochlorothiazide by Macleods Pharma Usa, Inc
D-0498-2024 - Presence of foreign substance
This Class II drug recall was voluntarily initiated by Macleods Pharma Usa, Inc on May 7, 2024 for the product Losartan Potassium And Hydrochlorothiazide. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0498-2024
Presence of foreign substance: plastic-like substance.
05-07-2024
05-22-2024
1,048 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
MACLEODS PHARMA USA, INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-050-44
Batch or Lot Expiration Information
Lot# : BLK2304A, Exp. 07/31/2025
