FDAClass IIIJanuary 11, 2023

Prochlorperazine Maleate Tablets recall: Subpotent

Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06

Why was Prochlorperazine Maleate Tablets recalled?

Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot#: 21P0336, Exp: 04/2023

Product
Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06
Recalling firm
Jubilant Cadista Pharmaceuticals, Inc.
Quantity
14,061 bottles
Distribution
Nationwide in the USA.
Recall date
January 11, 2023
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls