Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-10), c) 1000-count bottles (NDC # 33342-046-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Reported: May 11, 2022 Initiated: April 15, 2022 #D-0834-2022
Product Description
Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-10), c) 1000-count bottles (NDC # 33342-046-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Details
- Recalling Firm
- Macleods Pharma Usa Inc
- Units Affected
- 3288/30 count bottles; 23,904/90 count bottles; 3364/1000 count bottles = 5,614,000 tablets
- Distribution
- Product was distributed nationwide.
- Location
- Plainsboro, NJ
Frequently Asked Questions
What product was recalled? ▼
Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-10), c) 1000-count bottles (NDC # 33342-046-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536. Recalled by Macleods Pharma Usa Inc. Units affected: 3288/30 count bottles; 23,904/90 count bottles; 3364/1000 count bottles = 5,614,000 tablets.
Why was this product recalled? ▼
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 11, 2022. Severity: Moderate. Recall number: D-0834-2022.
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