RACEPINEPHRINE HYDROCHLORIDE Recall D-1324-2022
Description: Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of mild symptoms of intermittent asthma, Preservative Free, Sterile, For Oral Inhalation Only, 30 vials per box, Nephron Pharmaceuticals Corporation, NDC 0487-2784-01.
RACEPINEPHRINE HYDROCHLORIDE Recall D-1324-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1324-2022 |
| Event ID | 90553 |
| Brand | ASTHMANEFRIN |
| Generic Name | RACEPINEPHRINE HYDROCHLORIDE |
| Manufacturer | RACEPINEPHRINE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | RACEPINEPHRINE HYDROCHLORIDE |
| Drug Route | RESPIRATORY (INHALATION) |
| Distribution | Nationwide in the USA. |
| Quantity | 1 box |
| Recall Reason | CGMP Deviations: products were stored outside the drug label specifications. |
| Drug Classification | Class II |
| Drug Code Info | 20220817 |
| Product NDC | 0487-2784 |
| Drug UPC | 0304872784014 |
| Recall Initiation Date | 20220629 |
| Report Date | 20220817 |
| Classification Date | 20220805 |
| 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 | 336096P2WE |
| Drug Application Number | part341 |
| Structured Product Labeling (SPL ID) | b8a6aed9-a173-f172-e053-2995a90a17a0 |
| Structured Product Labeling (SPL Set ID) | 80480838-832c-4fdd-9f8e-f6f877ae3549 |
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