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Macleods Pharma USA, Inc FDA Recalls
19 recalls on file across drugs, 0 of them Class I and 2 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., PriClass IIFeb 26, 2026Subpotent Drug |
| Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: MacClass IIMay 7, 2024Presence of foreign substance: plastic-like substance. |
| Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 0Class IIIJan 5, 2023Mismatching of the embossing on the tablets (T7) with the em |
| Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., PlaiClass IIJun 16, 2022Shortfill: customer complaints of one to three tablets were |
| Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #33342-052-1Class IIJun 10, 2022CGMP Deviations- AZIDO Impurity levels observed to be above |
| Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-1Class IIApr 15, 2022CGMP Deviations- AZIDO Impurity levels observed to be above |
| Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33342-052-07), b) 90-counClass IIApr 15, 2022CGMP Deviations- AZIDO Impurity levels observed to be above |
| Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-Class IIApr 15, 2022CGMP Deviations- AZIDO Impurity levels observed to be above |
| Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles (NDC# 33342-050-07), b) 90-couClass IIApr 15, 2022CGMP Deviations- AZIDO Impurity levels observed to be above |
| Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044Class IIApr 15, 2022CGMP Deviations- AZIDO Impurity levels observed to be above |
| Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# 33342-051-07), b) 90-coClass IIApr 15, 2022CGMP Deviations- AZIDO Impurity levels observed to be above |
| Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ 0Class IIIMar 10, 2022FAILED CONTENT UNIFORMITY SPECIFICATIONS |
| Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08Class IIFeb 16, 2022cGmp Deviations |
| Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma Class IIFeb 15, 2022cGMP deviations |
| Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33Class IIIOct 18, 2021Out-of-specification test results obtained in Organic Impuri |
| Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Blister Packs, Rx only, MaClass IIIOct 18, 2021Out-of-specification test results obtained in Organic Impuri |
| Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blister Packs, Rx only, MaClass IIIOct 18, 2021Out-of-specification test results obtained in Organic Impuri |
| Clopidogrel Tablets, USP, 75 mg, 500-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ Class IIAug 2, 2021Presence of foreign matter |
| Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., PlainsClass IIIMar 22, 2021Failed Impurities/Degradation Specifications |