APRACLONIDINE HYDROCHLORIDE Recall D-1026-2022
Description: Aparaclonidine Ophthalmic Solution 0.5% as base, 0.5%, 5 mL bottle, Rx only, MFG:Sandoz Pharma, NDC 61314-665-05
APRACLONIDINE HYDROCHLORIDE Recall D-1026-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1026-2022 |
| Event ID | 89646 |
| Brand | APRACLONIDINE |
| Generic Name | APRACLONIDINE |
| Manufacturer | APRACLONIDINE |
| Original Package? | 1 |
| Active Substance | APRACLONIDINE HYDROCHLORIDE |
| Drug Route | OPHTHALMIC |
| Distribution | USA nationwide. |
| Quantity | 21 bottles |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 61314-665 |
| Drug UPC | 0361314665058 |
| 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 | D2VW67N38H |
| Drug Application Number | NDA020258 |
| Structured Product Labeling (SPL ID) | e67e69ac-f1e7-4e41-b7a3-63a14da106da |
| Structured Product Labeling (SPL Set ID) | 04ad82af-e7ba-4f40-a120-be9d33cf0c7b |
| Similar To |