Drug recall D-1519-2019
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 for recall
Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
Lots and codes
Lot #: 18246, Exp 09/2020
Recall details
- Recalling firm
- Bionpharma Inc., Princeton, NJ
- Quantity
- 3,020 bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 16, 2019
- Terminated
- March 5, 2020
Related products
- Clobazam – drug information
- NDC 69452-116 Clobazam · Clobazam 2.5 mg/mL · Bionpharma Inc.