PROCHLORPERAZINE MALEATE Recall D-0096-2023
Description: Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06
PROCHLORPERAZINE MALEATE Recall D-0096-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0096-2023 |
| Event ID | 91412 |
| Brand | PROCHLORPERAZINE MALEATE |
| Generic Name | PROCHLORPERAZINE MALEATE |
| Manufacturer | PROCHLORPERAZINE MALEATE |
| Original Package? | 1 |
| Active Substance | PROCHLORPERAZINE MALEATE |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA. |
| Quantity | 14,061 bottles |
| Recall Reason | Subpotent Drug: Out of specification for assay at the 18-month stability timepoint. |
| Drug Classification | Class III |
| Drug Code Info | 20230111 |
| Product NDC | 59746-113 59746-115 |
| Drug UPC | 0359746113063 0359746115067 |
| Recall Initiation Date | 20221227 |
| Report Date | 20230111 |
| Classification Date | 20230105 |
| Address | 207 Kiley Dr Salisbury, MD 21801-2249 United States |
| Recalling Firm | Jubilant Cadista Pharmaceuticals, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | I1T8O1JTL6 |
| Drug Application Number | ANDA040268 |
| Structured Product Labeling (SPL ID) | aeb0f87c-6809-496d-8162-72c2e405bde0 |
| Structured Product Labeling (SPL Set ID) | b05bc20e-cd19-ab40-1ad0-84a115d6d69e |
| Similar To |