Class III · Low risk Terminated
Phenobarbital Elixir
Reason Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
West-ward Belladonna Alkaloids with Phenobarbital Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks comprised of degraded organic material on tablets.
What was recalled
West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), b) 5000-count bottle (NDC 0143-1140-51), Rx only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724
- Recalling firm
- West-Ward Pharmaceutical Corp.
- NDC code
- 0143-1140-10
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-824-2013
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).
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.