NITROGLYCERIN Recall D-0372-2022
Description: Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx only, Manufactured by Perrigo, Yeruham, Israel; Distributed by Perrigo, Allegan, MI 49010, NDC 45802-210-02
NITROGLYCERIN Recall D-0372-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0372-2022 |
| Event ID | 89310 |
| Brand | NITROGLYCERIN LINGUAL |
| Generic Name | NITROGLYCERIN |
| Manufacturer | NITROGLYCERIN |
| Original Package? | 1 |
| Active Substance | NITROGLYCERIN |
| Drug Route | ORAL |
| Distribution | Nationwide USA |
| Quantity | 11,868 bottles |
| Recall Reason | Defective Delivery System |
| Drug Classification | Class II |
| Drug Code Info | 20220119 |
| Product NDC | 45802-210 |
| Product NUI | N0000175415 M0014874 N0000009909 |
| Pharma Class (PE) | Vasodilation [PE] |
| Pharma Class (EPC) | Nitrate Vasodilator [EPC] |
| Pharma Class (CS) | Nitrates [CS] |
| Recall Initiation Date | 20211227 |
| Report Date | 20220119 |
| Classification Date | 20220113 |
| Address | 3940 Quebec Ave N Minneapolis, MN 55427-1244 United States |
| Recalling Firm | Padagis US LLC |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Unique Ingredient Identifier | G59M7S0WS3 |
| Drug Application Number | ANDA091496 |
| Structured Product Labeling (SPL ID) | 5ac7bb7f-44e2-46e1-bb6b-420eabb4db8f |
| Structured Product Labeling (SPL Set ID) | e7bbeff1-e4f1-43a6-a1b3-a8c3dcae817d |
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