Drug 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.
D-1519-2019
Product summary
- Firm
- Bionpharma Inc.
- Event
- Event 83356
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,020 bottles
- Official record key
drug-enforcement:D-1519-2019
Official wording
Reason: Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
Code information: Lot #: 18246, Exp 09/2020
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Microbial contamination
Microbial Contamination
-
Potency or specification failure
Out-of-specification