Class III · Low risk Terminated
Phenobarbital Elixir
Reason Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Phenobarbital Oral Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
What was recalled
Phenobarbital Oral Solution, USP, 20 mg per 5 mL, Rx Only, One Pint (473 mL) bottle, NDC:16571-330-16, Manufactured by Bio-Pharm Inc., Levittown, PA 10957, Distributed by Rising Pharmaceuticals Inc., Saddle Brook, NJ 07663.
- Recalling firm
- Torrent Pharma Inc
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1365-2019
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Phenobarbital recalls
See all
Class II · Moderate risk Terminated
PHENOBARBITAL Sodium Injection
Reason Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
PHENOBARBITAL Sodium Injection
Reason Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Phenobarbital Tablets
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Phenobarbital Oral Solution
Reason Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
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