MECLIZINE HYDROCHLORIDE Recall D-0767-2022
Description: Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801, NDC 59746-122-06
MECLIZINE HYDROCHLORIDE Recall D-0767-2022 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0767-2022 |
| Event ID | 89854 |
| Brand | MECLIZINE HYDROCHLORIDE |
| Generic Name | MECLIZINE HYDROCLORIDE |
| Manufacturer | MECLIZINE HYDROCLORIDE |
| Original Package? | 1 |
| Active Substance | MECLIZINE HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | Product was distributed in Arkansas, Florida, North Carolina, South Carolina and Ohio. |
| Quantity | 12,174 bottles |
| Recall Reason | Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride |
| Drug Classification | Class I |
| Drug Code Info | 20220406 |
| Product NDC | 59746-121 59746-122 |
| Drug UPC | 0359746121068 0359746122065 |
| Recall Initiation Date | 20220308 |
| Report Date | 20220406 |
| Classification Date | 20220412 |
| Address | 207 Kiley Dr Salisbury, MD 21801-2249 United States |
| Recalling Firm | Jubilant Cadista Pharmaceuticals, Inc. |
| Initial Notification | |
| Unique Ingredient Identifier | HDP7W44CIO |
| Drug Application Number | ANDA040659 |
| Structured Product Labeling (SPL ID) | 9fbce799-a4af-48b2-95c8-4f5bcb5a5833 |
| Structured Product Labeling (SPL Set ID) | 9350fefc-9c00-182c-c3a9-044d4a40856f |
| Similar To |