CLONIDINE HYDROCHLORIDE Recall D-1091-2022
Description: Duraclon (clonidine HCl injection, USP), 1000 mcg/10 mL (100 mcg/mL), 10 mL single-dose vial, Rx only, MFG: Mylan Pharma, NDC 67457-218-10
CLONIDINE HYDROCHLORIDE Recall D-1091-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1091-2022 |
| Event ID | 89646 |
| Brand | DURACLON |
| Generic Name | CLONIDINE HYDROCHLORIDE |
| Manufacturer | CLONIDINE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | CLONIDINE HYDROCHLORIDE |
| Drug Route | EPIDURAL |
| Distribution | USA nationwide. |
| Quantity | 9 vials |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 67457-218 |
| 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 | W76I6XXF06 |
| Drug Application Number | NDA020615 |
| Structured Product Labeling (SPL ID) | 671a0224-c38b-4f2e-a132-fa38aa1a0797 |
| Structured Product Labeling (SPL Set ID) | 8c126bb8-732a-4949-8754-2f50b5543638 |
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