Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, I…
MACLEODS PHARMA USA, INC · Presence of foreign substance: plastic-like substance.
- Status
- Ongoing
- City
- Princeton
- State
- NJ
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 94592
- Recalling firm
- MACLEODS PHARMA USA, INC
- Address 1
- 103 College Rd E Fl 2
- Address 2
- N/A
- Postal code
- 08540-6611
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- N/A
- Distribution pattern
- USA Nationwide
- Recall number
- D-0498-2024
- Product quantity
- 1,048 bottles
- Reason for recall
- Presence of foreign substance: plastic-like substance.
- Recall initiation date
- 20240507
- Center classification date
- 20240515
- Report date
- 20240522
- Code info
- Lot #: BLK2304A, Exp. 07/31/2025
- 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
- Harmonized identifiers (openFDA)
- Application number
- ANDA202289
- Brand name
- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
- Generic name
- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
- Manufacturer name
- Macleods Pharmaceuticals Limited
- Product NDC
- 33342-050, 33342-051, 33342-052
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE
- RxCUI
- 979464, 979468, 979471
- SPL ID
- cf31d31e-9355-47da-9c2b-8e4b84ac8159
- SPL set ID
- a04b5622-2c49-4d61-92b1-5dc523af7a24
- Package NDC
- 33342-050-07, 33342-050-10, 33342-050-44, 33342-050-12, 33342-051-07, 33342-051-10, 33342-051-44, 33342-051-12, 33342-052-07, 33342-052-10, 33342-052-44, 33342-052-12
- Is original packager
- true
- Upc
- 0333342051448, 0333342050106, 0333342052100, 0333342051103, 0333342052445, 0333342051073, 0333342052070
- Nui
- N0000175359, N0000175419, M0471776
- Pharm class pe
- Increased Diuresis [PE]
- Pharm class epc
- Thiazide Diuretic [EPC]
- Pharm class cs
- Thiazides [CS]
- UNII
- 3ST302B24A, 0J48LPH2TH