Recall: D-0096-2023

Class III - Minor Violations

Class IIIClassification

2022-12-27Initiated

TerminatedStatus

Jubilant Cadista PharmaceuticaFirm

Product

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

Reason

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

Distribution

Nationwide in the USA.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.