RACEPINEPHRINE HYDROCHLORIDE Recall D-1325-2022
Description: Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhalation Only, Sulfite Free, Preservative Free, 30 x 0.5 mL Sterile Unit-of-Use Vials, each in a foil pouch, per carton, Nephron Pharmaceuticals Corporation, NDC 0487-5901-99.
RACEPINEPHRINE HYDROCHLORIDE Recall D-1325-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1325-2022 |
| Event ID | 90553 |
| Brand | S2 |
| Generic Name | RACEPINEPHRINE HYDROCHLORIDE |
| Manufacturer | RACEPINEPHRINE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | RACEPINEPHRINE HYDROCHLORIDE |
| Drug Route | RESPIRATORY (INHALATION) |
| Distribution | Nationwide in the USA. |
| Quantity | 23 cartons |
| Recall Reason | CGMP Deviations: products were stored outside the drug label specifications. |
| Drug Classification | Class II |
| Drug Code Info | 20220817 |
| Product NDC | 0487-5901 |
| Drug UPC | 0304875901999 |
| 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) | b8a789aa-55e6-6497-e053-2a95a90a4169 |
| Structured Product Labeling (SPL Set ID) | dd1b35c7-b23b-4b95-8162-df3d263fe32e |
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