FDAFDA · Food and drugs·Recall number D-0087-2022
Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only
Published November 10, 2021 · Recall initiated: October 12, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- IRBESARTAN
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Distributor
- Product was distributed to major distributors who may have further distributed the product nationwide.
- Lot
- a) Lot# H804403, exp. date 31/08/2021 H805251, exp. date 30/11/2021 H805640, exp. date 30/11/2021 H901580; exp. date 30/04/2022 b) Lot# H804492, exp. date 31/08/2021 H805252, exp. date 30/11/2021 H805253, exp. date30/11/2021 H805641, exp. date30/11/2021 H805642, exp. date30/11/2021 H805643, exp. date 30/11/2021 H901581, exp. date 30/04/2021 H902139, exp. date 30/04/2022 H902140, exp. date 30/04/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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