FDA Drug recall D-1519-2019
Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: Bionpharma Inc., 600 Alexander Road, Princeton, NJ 08540, NDC…
- FDA Drug
- Class II
- terminated
- Published 2019-07-31
On 2019-07-31 the FDA classified a Class II recall of Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: Bionpharma Inc., 600 Alexander Road, Princeton, NJ 08540, NDC… by Bionpharma, citing microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1519-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-16 |
| Published | 2019-07-31 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Bionpharma |
| Distribution | US |
Product
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.
Reason
Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
Identifiers
| ndc | 69452-116-45 |
|---|---|
| code_info | Lot #: 18246, Exp 09/2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1519-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.