PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: January 11, 2023 Initiated: December 27, 2022 #D-0096-2023

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.

Details

Units Affected
14,061 bottles
Distribution
Nationwide in the USA.
Location
Salisbury, MD

Frequently Asked Questions

What product was recalled?
Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06. Recalled by Jubilant Cadista Pharmaceuticals, Inc.. Units affected: 14,061 bottles.
Why was this product recalled?
Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 11, 2023. Severity: Low. Recall number: D-0096-2023.