PAPAVERINE HYDROCHLORIDE Recall D-0742-2022
Description: PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL Single Use Vials per box (NDC 72516-024-25) and b) 10 x 2mL Single Use Vials per box (NDC 72516-024-10); Manufactured for Oryza Pharmaceuticals, Inc.
PAPAVERINE HYDROCHLORIDE Recall D-0742-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0742-2022 |
| Event ID | 89803 |
| Brand | PAPAVERINE HYDROCHLORIDE |
| Generic Name | PAPAVERINE HYDROCHLORIDE |
| Manufacturer | PAPAVERINE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | PAPAVERINE HYDROCHLORIDE |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide in the U.S.A |
| Quantity | a) 2,098 boxes; b) 700 boxes |
| Recall Reason | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. |
| Drug Classification | Class II |
| Drug Code Info | 20220413 |
| Product NDC | 72516-024 |
| Recall Initiation Date | 20220314 |
| Report Date | 20220413 |
| Classification Date | 20220405 |
| Address | 3030 Bunker Hill St Ste 203 San Diego, CA 92109-5754 United States |
| Recalling Firm | Vitae Enim Vitae Scientific, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Unique Ingredient Identifier | 23473EC6BQ |
| Structured Product Labeling (SPL ID) | 160e9fb1-4feb-45d6-84d7-14244a9501cf |
| Structured Product Labeling (SPL Set ID) | 5ba6e650-a5b5-4381-a62a-b7a6df73e8e6 |
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