Clonazepam Orally Disintegrating Tablet, USP, 2 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#: 49884-310-02 (carton), NDC#: 49884-310-52 (blisters).
Reported: January 15, 2025 Initiated: November 18, 2024 #D-0178-2025
Product Description
Clonazepam Orally Disintegrating Tablet, USP, 2 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#: 49884-310-02 (carton), NDC#: 49884-310-52 (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.
Details
- Recalling Firm
- Endo USA, Inc.
- Units Affected
- 9,816 cartons
- Distribution
- Nationwide in the USA
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
Clonazepam Orally Disintegrating Tablet, USP, 2 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#: 49884-310-02 (carton), NDC#: 49884-310-52 (blisters).. Recalled by Endo USA, Inc.. Units affected: 9,816 cartons.
Why was this product recalled? ▼
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 15, 2025. Severity: Critical. Recall number: D-0178-2025.
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