Class III · Low risk
Phenobarbital Elixir
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
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
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
Affected NDC
0463-6160-10
Compare with the code on your package — it is the most precise check available.
Drug: Phenobarbital
- 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 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Phenobarbital recalls
See all
Class II · Moderate risk
PHENOBARBITAL Sodium Injection
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
PHENOBARBITAL Sodium Injection
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
Phenobarbital Tablets
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Phenobarbital Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Other recalls by C. O. Truxton
All 2017 recalls
Class II · Moderate risk
Phenobarbital Tablets USP
Labeling: Label Mixup; potentially mislabeled
Class II · Moderate risk
Amitriptyline HCL Tablets
Labeling: Label Mixup; potentially mislabeled
Class II · Moderate risk
Phenobarbital Tablets USP
Labeling: Label Mixup; potentially mislabeled
Class II · Moderate risk
Phenobarbital Tablets USP
Labeling: Label Mixup; potentially mislabeled
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