Losartan HCTZ 50/12.5 mg recall: Impurity Out of Spec
Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
Why was Losartan HCTZ 50/12.5 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 # B1377711-100521, exp. date 10/31/2022 B1412137-102621, exp. date 10/31/2022
- Product
- Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
- Recalling firm
- RemedyRepack Inc.
- Quantity
- 22 bottles/90 count each
- Distribution
- Recalled product was distributed to Florida.
- Recall date
- June 1, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)