PRAZOSIN HYDROCHLORIDE Recall D-1093-2022
Description: Prazosin Hydrochloride Capsules, USP, 1 mg, 100-count bottle, Rx only, MFG: Mylan Pharma, NDC 0378-1101-01
PRAZOSIN HYDROCHLORIDE Recall D-1093-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1093-2022 |
| Event ID | 89646 |
| Brand | PRAZOSIN HYDROCHLORIDE |
| Generic Name | PRAZOSIN HYDROCHLORIDE |
| Manufacturer | PRAZOSIN HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | PRAZOSIN HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | USA nationwide. |
| Quantity | 8 bottles/100 tablets each |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0378-1101 0378-2302 0378-3205 |
| 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 | X0Z7454B90 |
| Drug Application Number | ANDA072575 |
| Structured Product Labeling (SPL ID) | 376d081e-5363-4c60-8d5a-f1d95cd3c41b |
| Structured Product Labeling (SPL Set ID) | 1ce90aaf-d075-4617-9a47-e8d922096d23 |
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