December 2022 FDA Recall Prochlorperazine Maleate by Jubilant Cadista Pharmaceuticals, Inc.
D-0096-2023 - Subpotent Drug
This Class III drug recall was voluntarily initiated by Jubilant Cadista Pharmaceuticals, Inc. on December 27, 2022 for the product Prochlorperazine Maleate. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0096-2023
Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
12-27-2022
01-11-2023
14,061 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Jubilant Cadista Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA.
12-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
