FDA recall D-0179-2025

Product

Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-306-02 (carton), NDC #: 49884-306-52 (blisters).

Reason for recall

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2024-11-18

Report date

2025-01-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0179-2025