FDA Drug recall 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
- FDA Drug
- Class II
- terminated
- Published 2021-11-10
On 2021-11-10 the FDA classified a Class II recall of Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) 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-0086-2022 |
| 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, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) 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# H000843, exp. date 28/02/2023 H805727, exp. date 30/11/2021 H901579, exp. date 31/03/2022 b) Lot# H0…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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0086-2022%22
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