Losartan Potassium Tablets Recalled for AZIDO Impurity Above Limits
Preferred Pharmaceuticals is recalling Losartan Potassium 50mg tablets due to AZIDO impurity levels exceeding acceptable limits. The affected product was distributed to California, Indiana, and Florida.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II pharmaceutical recall for CGMP deviation with AZIDO impurity levels exceeding acceptable limits. No illnesses or injuries have been reported, making this a potential risk-of-harm product without yet-documented harm, consistent with the High severity threshold.
Plain-English summary
Preferred Pharmaceuticals, Inc. is recalling certain batches of Losartan Potassium Tablet USP 50mg due to a current good manufacturing practice (CGMP) deviation involving elevated AZIDO impurity levels. The affected product was distributed nationwide to California, Indiana, and Florida.
The recalled lots are E1321O, E2521H, and E2621F, all expiring May 31, 2023. The total quantity includes 44 bottles containing 90 tablets each and 33 bottles containing 30 tablets each.
Patients taking Losartan Potassium from the affected lots should consult their healthcare provider or pharmacist to determine if their medication is included in this recall. Do not stop taking the medication without medical guidance.
The recalled product
- Product
- Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, Inc., Preferred Pharmaceuticals, Inc.
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Category
- Drug — Antihypertensive
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot: E1321O
- Exp.: 5/31/2023 Lot: E2521H
- Exp.: 5/31/2023 Lot: E2621F
- Exp.: 5/31/2023
Distribution
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