Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks comprised of degraded organic material on tablets.
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
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.
Reason Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Reason Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products…
Reason Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
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