NITROGLYCERIN Recall D-1049-2022
Description: Nitrostat (Nitroglycerin Sublingual Tablets, USP) 0.4 mg/tablet, 25-count bottle, Rx only, Distributed by: Pfizer Parke-Davis, Division of Pfizer Inc., NDC 0071-0418-13
NITROGLYCERIN Recall D-1049-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1049-2022 |
| Event ID | 89646 |
| Brand | NITROSTAT |
| Generic Name | NITROGLYCERIN |
| Manufacturer | NITROGLYCERIN |
| Original Package? | 1 |
| Active Substance | NITROGLYCERIN |
| Drug Route | SUBLINGUAL |
| Distribution | USA nationwide. |
| Quantity | 1 carton/4 bottles per carton/25 tablets per bottle |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0071-0417 0071-0418 0071-0419 |
| Product NUI | N0000175415 M0014874 N0000009909 |
| Drug UPC | 0300710417243 0300710419247 |
| Pharma Class (PE) | Vasodilation [PE] |
| Pharma Class (EPC) | Nitrate Vasodilator [EPC] |
| Pharma Class (CS) | Nitrates [CS] |
| Recall Initiation Date | 20220413 |
| Report Date | 20220615 |
| Classification Date | 20220609 |
| Address | 9954 Maryland DriveDeep Run Iii Ste. 4000 Richmond, VA 23233 United States |
| Recalling Firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Initial Notification | Letter |
| Unique Ingredient Identifier | G59M7S0WS3 |
| Drug Application Number | NDA021134 |
| Structured Product Labeling (SPL ID) | b21bdc0d-86ca-4a5f-9695-a7a8064f5bed |
| Structured Product Labeling (SPL Set ID) | 79ba021e-183c-4b4d-822e-4ff5ef54ca61 |
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