Losartan Potassium and HCTZ Tablets Recalled for AZIDO Impurity Deviations
Preferred Pharmaceuticals is recalling specific lots of Losartan Potassium & HCTZ Tablets due to AZIDO impurity levels exceeding acceptable manufacturing standards. The recalled tablets were distributed in Florida and California.
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 involving impurity levels above acceptable manufacturing standards. This represents a risk-of-harm product where injury has not been reported, meeting the High (3) severity criterion.
Plain-English summary
Preferred Pharmaceuticals, Inc. is recalling specific lots of Losartan Potassium & HCTZ Tablets 50mg/12.5 mg due to current good manufacturing practice (CGMP) deviations. Testing detected AZIDO impurity levels above acceptable limits in the affected product.
The recall affects two lot numbers: K1721E (47 bottles, expiration 4/30/2023) and H3021Q (35 bottles, expiration 2/28/2023). These tablets were distributed in Florida and California.
Consumers in possession of the affected lots should discontinue use and contact their healthcare provider or pharmacist for instructions on obtaining replacement medication.
The recalled product
- Product
- Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03.
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Category
- Drug
- Hazard
- azido-impurity
- cgmp-deviation
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 (6)
- Lot: K1721E
- EXP: 4/30/2023
- NDC: 68788-7758-03
- Lot: H3021Q
- EXP: 2/28/2023
- NDC: 68788-7758-03.
Distribution
Distributed in 2 states:
- CA
- FL
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