PROMETHAZINE HYDROCHLORIDE Recall D-1057-2022
Description: Promethazine HCl Tablets, USP, 25 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-6461-61
PROMETHAZINE HYDROCHLORIDE Recall D-1057-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1057-2022 |
| Event ID | 89646 |
| Brand | PROMETHAZINE HYDROCHLORIDE |
| Generic Name | PROMETHAZINE HYDROCHLORIDE |
| Manufacturer | PROMETHAZINE HYDROCHLORIDE |
| Active Substance | PROMETHAZINE HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | USA nationwide. |
| Quantity | 16 cartons/100 blisters packs per carton |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0904-6461 |
| 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 | R61ZEH7I1I |
| Drug Application Number | ANDA084176 |
| Structured Product Labeling (SPL ID) | 85e0d628-0315-4ea2-b604-2b86a31ac2ce |
| Structured Product Labeling (SPL Set ID) | 3936f9fe-0bb8-447f-aa7f-1ddb0126f3ab |
| Similar To |