Class III · Low risk
Phenobarbital Elixir
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Phenobarbital Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
Phenobarbital Tablets, USP 32.4 mg 100 tablets Rx only NdC 13517-111-01 Manufactured for: e5 Pharma, LLC., Boca Raton, FL 33432
Affected NDC
13517-0111-01
Compare with the code on your package — it is the most precise check available.
Drug: Phenobarbital
- Recalling firm
- Cardinal Health Inc.
- NDC code
- 13517-111-01
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0470-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. 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 Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Phenobarbital Oral Solution
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Other recalls by Cardinal Health Inc.
All 2021 recalls
Class II · Moderate risk
Enoxaparin Sodium Injection
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Class II · Moderate risk
Recombinate
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
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