FDAFDA · Food and drugs·Recall number D-0086-2022
Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) 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# H000843, exp. date 28/02/2023 H805727, exp. date 30/11/2021 H901579, exp. date 31/03/2022 b) Lot# H000844, exp. date 28/02/2023 H000964, exp. date 31/03/2023 H804311, exp. date 31/08/2021 H805267, exp. date 30/11/2021 H805268, exp. date 30/11/2021 H805269, exp. date 30/11/2021 H805725, exp. date 30/11/2021 H805726, exp. date 30/11/2021 H901497, exp. date 31/01/2022 H901577, exp. date 31/03/2022 H901578, exp. date 31/03/2022 H902258, exp. date 31/05/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.