Recalls / Class II
Class IID-0498-2024
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
- Brand name
- Losartan Potassium And Hydrochlorothiazide
- Generic name
- Losartan Potassium And Hydrochlorothiazide
- Active ingredients
- Hydrochlorothiazide, Losartan Potassium
- Route
- Oral
- NDCs
- 33342-050, 33342-051, 33342-052
- FDA application
- ANDA202289
- Affected lot / code info
- Lot #: BLK2304A, Exp. 07/31/2025
Why it was recalled
Presence of foreign substance: plastic-like substance.
Recalling firm
- Firm
- MACLEODS PHARMA USA, INC
- Manufacturer
- Macleods Pharmaceuticals Limited
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 103 College Rd E Fl 2, N/A, Princeton, New Jersey 08540-6611
Distribution
- Quantity
- 1,048 bottles
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2024-05-07
- FDA classified
- 2024-05-15
- Posted by FDA
- 2024-05-22
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0498-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.