LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
Reported: February 27, 2019 Initiated: December 20, 2018 #D-0503-2019
Product Description
LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
Reason for Recall
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Details
- Recalling Firm
- Torrent Pharma Inc.
- Units Affected
- 43,416 bottles
- Distribution
- Nationwide USA and Puerto Rico
- Location
- Kalamazoo, MI
Frequently Asked Questions
What product was recalled? ▼
LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda. Recalled by Torrent Pharma Inc.. Units affected: 43,416 bottles.
Why was this product recalled? ▼
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 27, 2019. Severity: Moderate. Recall number: D-0503-2019.
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