Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals...
FDA Recall #D-0096-2023 — Class III — December 27, 2022
Product Description
Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06
Reason for Recall
Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
Recalling Firm
Jubilant Cadista Pharmaceuticals, Inc. — Salisbury, MD
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
14,061 bottles
Distribution
Nationwide in the USA.
Code Information
Lot#: 21P0336, Exp: 04/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated