FDA recall D-0096-2023

Product

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.

Distribution

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2022-12-27

Report date

2023-01-11

Termination date

2023-12-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salisbury, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0096-2023