drugs MODERATE Updated 2019-07-31

Bionpharma Inc. recalls Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only,

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Recalled 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.

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Hazard / Issue

Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: 18246, Exp 09/2020

✅ What Should You Do?

  1. 1Stop taking this medication and contact your doctor or pharmacist immediately.
  2. 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
  3. 3Check the lot number on your bottle or packaging against the recalled lots listed above.
  4. 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.

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