Irbesartan and Hydrochlorothiazide Tablets USP recall: Impurity Out of Spec
Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09) bottles, Rx only
Why was Irbesartan and Hydrochlorothiazide Tablets USP recalled?
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
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?
a) Lot# H804537, exp. date 30/09/2021 H805148, exp. date 31/10/2021 H900063, exp. date 31/10/2021 H900522, exp. date 31/12/2021 H901582, exp. date 31/01/2022 b) Lot# H000963, exp. date 30/04/2022 H804507, exp. date 30/04/2022 H804536, exp. date 30/09/2021 H805070, exp. date 31/10/2021 H805149, exp. date 31/10/2021 H900064, exp. date 31/12/2021 H900523, exp. date 31/01/2022 H901583, exp. date 30/04/2022 H902530, exp. date 30/04/2022
- Product
- Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09) bottles, Rx only
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Quantity
- 63,408 bottles
- Distribution
- Product was distributed to major distributors who may have further distributed the product nationwide.
- Recall date
- November 10, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)