Prochlorperazine Maleate Tablet
FDA Recall NDC 59746-113
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Prochlorperazine Maleate (NDC 59746-113). A significant event, classified as Class III, was initiated on Dec 27, 2022 by Jubilant Cadista Pharmaceuticals Inc.. The reported reason for this action was: "Subpotent Drug: Out of specification for assay at the 18-month stability timepoint."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
Dec 27, 2022
Jan 11, 2023
14,061 bottles
Recall Profile & Regulatory Data
Event ID
91412
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Jubilant Cadista Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Dec 05, 2023
Product Description
Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06
Batch or Lot Expiration Information
Lot# : 21P0336, Exp: 04/2023
Affected Packages Involved in this Recall
59746-113-06Product
59746-113-10Product
59746-115-06Product
59746-115-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
