Why it was recalled
Presence of foreign substance: plastic-like substance.
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
Lot numbers, UPCs & expiration codes
Lot #: BLK2304A, Exp. 07/31/2025
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0498-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 7, 2024
- FDA report date
- May 22, 2024
- Quantity
- 1,048 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- MACLEODS PHARMA USA, INC
Original FDA data
Every field from FDA enforcement report D-0498-2024, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94592
- Address
- 103 College Rd E Fl 2
- Code information
- Lot #: BLK2304A, Exp. 07/31/2025
- Postal code
- 08540-6611
- Report date
- May 22, 2024
- Product type
- Drugs
- Recall number
- D-0498-2024
- Classification
- Class II
- Recalling firm
- MACLEODS PHARMA USA, INC
- Product quantity
- 1,048 bottles
- Reason for recall
- Presence of foreign substance: plastic-like substance.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- USA Nationwide
- Recall initiation date
- May 7, 2024
- Center classification date
- May 15, 2024