Recalls / Class II
Class IID-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.
- Brand name
- Clobazam
- Generic name
- Clobazam
- Active ingredient
- Clobazam
- Route
- Oral
- NDC
- 69452-116
- FDA application
- ANDA208819
- Affected lot / code info
- Lot #: 18246, Exp 09/2020
Why it was recalled
Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
Recalling firm
- Firm
- Bionpharma Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 600 Alexander Rd Ste 2-4b, N/A, Princeton, New Jersey 08540-6013
Distribution
- Quantity
- 3,020 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-07-16
- FDA classified
- 2019-07-25
- Posted by FDA
- 2019-07-31
- Terminated
- 2020-03-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1519-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.