Class II · Moderate risk
Clobazam Tablets
Presence of Foreign Tablets/Capsules
Clobazam Oral Suspension
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What was recalled
Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: Bionpharma Inc., 600 Alexander Road, Princeton, NJ 08540, NDC 69452-116-45.
Affected NDC
69452-0116-45
Compare with the code on your package — it is the most precise check available.
Drug: Clobazam
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 |
|---|---|---|---|---|
| Clobazam NDC 69452-0116 |
2.5 mg/mL | Suspension Oral |
Bionpharma Inc. | Rx · CIV |
- Recalling firm
- Bionpharma Inc.
- NDC code
- 69452-116-45
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1519-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Clobazam recalls
See all
Class II · Moderate risk
Clobazam Tablets
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Clobazam Tablets 10mg
CGMP Deviations: Out of specification for residual solvents.
Class II · Moderate risk
Clobazam Tablets
CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk
Clobazam Tablets
CGMP Deviations: Potential risk of Cross Contamination
Other recalls by Bionpharma Inc.
All 2019 recalls
Class III · Low risk
Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Divalproex Sodium Delayed-Release Tablets
Presence of Foreign Tablets/Capsules
Class I · High risk
Atovaquone Oral Suspension
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
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