Class I · High risk
Clonazepam Orally Disintegrating Tablets
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Clonazepam Orally Disintegrating Tablets
Class I — High risk. Reasonable probability of serious harm or death.
Why it was 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.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What 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.
Affected NDC
49884-0306-02
Compare with the code on your package — it is the most precise check available.
Drug: Clonazepam Category: Mental Health Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Clonazepam NDC 49884-0306 |
.125 mg/1 | Tablet, Orally Disintegrating Oral |
Par Health USA, LLC | Rx · CIV |
- Recalling firm
- Endo Pharmaceuticals, Inc.
- NDC code
- 49884-306-02
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Jul 16, 2024 · FDA notice with lot numbers
- FDA recall number
- D-0622-2024 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Clonazepam recalls
See all
Class I · High risk
Clonazepam Orally Disintegrating Tablets
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Class I · High risk
Clonazepam Orally Disintegrating Tablets
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Class I · High risk
Clonazepam Orally Disintegrating Tablet
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Class II · Moderate risk
Clonazepam Orally Disintegrating Tablets
Failed Tablet/Capsule Specification; oversized tablet found in a bottle
Other recalls by Endo Pharmaceuticals, Inc.
All 2024 recalls
Class II · Moderate risk
Calcitonin Salmon Nasal Spray
Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.
Class I · High risk
robaxin-750
Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly states "Two to four tablets four times daily." rather than the correct dosage of "Two tablets three times daily."
Class II · Moderate risk
Edex (alprostadil for injection)
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
Class III · Low risk
Endocet (oxycodone and acetaminophen)
Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in a bottle with Endocet 10 mg/650 mg tablets.
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