Losartan HCTZ 100/12.5 mg recall: Impurity Out of Spec
Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09
Why was Losartan HCTZ 100/12.5 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 # B1364261-092721, exp. date 09/30/2022 B1377667-100521, exp. date 10/31/2022 B1412576-102621, exp. date 10/31/2022 B1436925-111321, exp. date 11/30/2022
- Product
- Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09
- Recalling firm
- RemedyRepack Inc.
- Quantity
- 30 bottles/90 count = 2,700 tablets
- Distribution
- Product was distributed to FL, SC and VA
- Recall date
- June 1, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)