Losartan Potassium & HCTZ Tablets 50mg/12.5 mg recall: Impurity Out of Spec
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03.
Why was Losartan Potassium & HCTZ Tablets 50mg/12.5 mg recalled?
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: K1721E, EXP: 4/30/2023, NDC: 68788-7758-03; Lot: H3021Q, EXP: 2/28/2023, NDC: 68788-7758-03.
- Product
- Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03.
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- Quantity
- 47 Bottles of 30 Tabs (K1721E); 35 Bottles of 30 Tabs (H3021Q).
- Distribution
- Within the U.S in FL and CA.
- Recall date
- June 1, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)