PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: May 22, 2024 Initiated: May 7, 2024 #D-0498-2024

Product Description

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

Reason for Recall

Presence of foreign substance: plastic-like substance.

Details

Recalling Firm
MACLEODS PHARMA USA, INC
Units Affected
1,048 bottles
Distribution
USA Nationwide
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by MACLEODS PHARMA USA, INC. Units affected: 1,048 bottles.
Why was this product recalled?
Presence of foreign substance: plastic-like substance.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 22, 2024. Severity: Moderate. Recall number: D-0498-2024.