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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