Class II
Terminated
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.
This recall has been terminated (originally issued July 31, 2019).
- Company
- Bionpharma Inc.
- Recall Initiated
- July 16, 2019
- Posted
- July 31, 2019
- Recall Number
- D-1519-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3,020 bottles
- Firm Location
- Princeton, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
Distribution
Nationwide in the USA
Lot / Code Info
Lot #: 18246, Exp 09/2020
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