Drug recall
Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: Bionpharma Inc., 600 Alexander…
FDA recall event 83356 · Class II · Bionpharma Inc.
Key facts
| Event ID | 83356 |
|---|---|
| Recall numbers | D-1519-2019 |
| Recalling firm | Bionpharma Inc. |
| Product type | Drugs |
| Products | 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. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed. |
| Initiation date | Jul 16, 2019 |
| Report date | Jul 31, 2019 |
| Termination date | Mar 5, 2020 |
| City | Princeton |
| State | NJ |
| Country | United States |
| FEI number | 3011705836 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: