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.
Reported: July 31, 2019 Initiated: July 16, 2019 #D-1519-2019
Product Description
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 for Recall
Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
Details
- Recalling Firm
- Bionpharma Inc.
- Units Affected
- 3,020 bottles
- Distribution
- Nationwide in the USA
- Location
- Princeton, NJ
Frequently Asked Questions
What product 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.. Recalled by Bionpharma Inc.. Units affected: 3,020 bottles.
Why was this product recalled? ▼
Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 31, 2019. Severity: Moderate. Recall number: D-1519-2019.
Related Recalls
CPSC Moderate
Huaker Magnetic Balls and Rods Sets Recalled Due to Risk of Serious Injury or Death from Choking; Violates the Small Ba…
Shenzhen Huakechuang Technology Co. Ltd., dba Huaker, of China · 2026-02-19
CPSC Moderate
JJGoo LED Balloon Lights Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Sta…
Shenzhen Yimu Technology Co., Ltd. dba JJGoo, of China · 2026-02-19
CPSC Moderate
Joly's Recalls 80% Vinegar Due to Risk of Serious Injury or Death from Poisoning and Chemical Burns; Violates FHSA Labe…
Joly's LLC, of Orlando, Florida · 2026-02-19
CPSC Moderate
Prismatic 3D Prints Recalls Book Nooks Due to Risk of Serious Injury or Death Battery Ingestion; Violates Mandatory Sta…
Prismatic 3D Prints LLC of Loveland, Colorado · 2026-02-19
CPSC Moderate
SAMIT Youth Multi-Purpose Helmets Recalled Due to Risk of Serious Injury or Death from Head Injury; Violates Mandatory …
Shenzhenshilonghuaqujialebeibaihuoshanghang (Jialebei Department Store, Longhua District, Shenzhen) dba Samit Outdoor, of China · 2026-02-19