D-1519-2019 Class II Terminated
FDA drug recall D-1519-2019 was initiated by Bionpharma Inc. on July 16, 2019 and is designated Class II. Reason for recall: Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed. The recall status is terminated (terminated March 5, 2020). Affected quantity: 3,020 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 31, 2019
- Initiation Date
- July 16, 2019
- Termination Date
- March 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,020 bottles
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 18246, Exp 09/2020