Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets 40 mg/10 mg/12.5mg, packaged as a) 30-count bottle, NDC 33342-246-07; b)…
MACLEODS PHARMA USA, INC · Failed Dissolution Specifications.
- Status
- Ongoing
- City
- Princeton
- State
- NJ
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 100113
- Recalling firm
- MACLEODS PHARMA USA, INC
- Address 1
- 103 College Rd E Fl 2
- Postal code
- 08540-6611
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
- Recall number
- D-0077-2027
- Product quantity
- 3528 30-count and 216 90-count bottles
- Reason for recall
- Failed Dissolution Specifications.
- Recall initiation date
- 20261007
- Center classification date
- 20261026
- Report date
- 20261104
- Code info
- Lot #: a) 12251163A, Exp 05-31-2027; b) 12251163B, Exp 05-31-2027
- Product description
Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets 40 mg/10 mg/12.5mg, packaged as a) 30-count bottle, NDC 33342-246-07; b) 90-count bottle, NDC 33342-246-10; Rx Only, Manufactured for : Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd, Daman, 396210, India
- Harmonized identifiers (openFDA)
- Application number
- ANDA207088
- Brand name
- OLMESARTAN MEDOXOMIL AMLODIPINE AND HYDROCHLOROTHIAZIDE
- Generic name
- OLMESARTAN MEDOXOMIL AMLODIPINE AND HYDROCHLOROTHIAZIDE
- Manufacturer name
- Macleods Pharmaceuticals Limited
- Product NDC
- 33342-243, 33342-244, 33342-245, 33342-246, 33342-247
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE, HYDROCHLOROTHIAZIDE
- RxCUI
- 999967, 999986, 999991, 999996, 1000001
- SPL ID
- 52c013e1-8c31-4bed-9241-e7845873ebe8
- SPL set ID
- 52c013e1-8c31-4bed-9241-e7845873ebe8
- Package NDC
- 33342-243-07, 33342-243-10, 33342-244-07, 33342-244-10, 33342-245-07, 33342-245-10, 33342-246-07, 33342-246-10, 33342-247-07, 33342-247-10
- Is original packager
- true
- Upc
- 0333342247070, 0333342245076
- Nui
- N0000175359, N0000175419, M0471776
- Pharm class pe
- Increased Diuresis [PE]
- Pharm class epc
- Thiazide Diuretic [EPC]
- Pharm class cs
- Thiazides [CS]
- UNII
- 6M97XTV3HD, 0J48LPH2TH, 864V2Q084H