Class III · Low risk Terminated
Phenobarbital Elixir
Reason Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Phenobarbital Tablets USP
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets
What was recalled
Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6160-10
- Recalling firm
- C. O. Truxton
- NDC code
- 0463-6160-10
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1111-2017
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 cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
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