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
Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01
Affected NDC
0143-1455-01
Compare with the code on your package — it is the most precise check available.
Drug: Phenobarbital
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Phenobarbital NDC 00143-1455 |
60 mg/1 | Tablet Oral |
Hikma Pharmaceuticals USA Inc. | Rx · CIV |
- Recalling firm
- West-Ward Pharmaceuticals Corp.
- NDC code
- 0143-1455-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1045-2017 · 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 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 West-Ward Pharmaceuticals Corp.
All 2016 recalls
Class III · Low risk
Dexamethasone Sodium Phosphate Injection
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Class III · Low risk
Dexamethasone Sodium Phosphate Injection
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Class III · Low risk
Sodium Ferric Gluconate Complex in Sucrose Injection
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
Class III · Low risk
Amoxicillin for Oral suspension
Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
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