FDA Drug recall D-0088-2022
Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only
- FDA Drug
- Class II
- terminated
- Published 2021-11-10
On 2021-11-10 the FDA classified a Class II recall of Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only by Lupin Pharmaceuticals, citing CGMP Deviations: impurity N-nitrosoirbesartan detected in API.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0088-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-10-12 |
| Published | 2021-11-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
Product
Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only
Reason
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Identifiers
| ndc | 68180-410-06 |
|---|---|
| ndc | 68180-410-09 |
| ndc | 68180-411-02 |
| ndc | 68180-411-06 |
| ndc | 68180-411-09 |
| ndc | 68180-412-02 |
| ndc | 68180-412-06 |
| ndc | 68180-412-09 |
| code_info | a) Lot# H804310, exp. date 31/08/2021 H900050, exp. date 30/11/2021 H902262, exp. date 31/05/2022 b) Lot# H0…a) Lot# H804310, exp. date 31/08/2021 H900050, exp. date 30/11/2021 H902262, exp. date 31/05/2022 b) Lot# H000845, exp. date 28/02/2023 H000846, exp. date 28/02/2023 H000965, exp. date 31/03/2023 H805345, exp. date 30/11/2021 H805346, exp. date 30/11/2021 H805347, exp. date 30/11/2021 H805724, exp. date 30/11/2021 H900061, exp. date 31/12/2021 H900062, exp. date 31/12/2021 H900445, exp. date 31/01/2022 H901489, exp. date 31/03/2022 H901490, exp. date 31/03/2022 H901491, exp. date 31/03/2022 H902261, exp. date 31/05/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0088-2022%22
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