Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC# 49884-306-02.
Reported: August 7, 2024 Initiated: July 10, 2024 #D-0622-2024
Product Description
Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC# 49884-306-02.
Reason for Recall
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.
Details
- Recalling Firm
- Endo Pharmaceuticals, Inc.
- Units Affected
- 8,139 cartons
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC# 49884-306-02.. Recalled by Endo Pharmaceuticals, Inc.. Units affected: 8,139 cartons.
Why was this product recalled? ▼
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 7, 2024. Severity: Critical. Recall number: D-0622-2024.
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