Phenobarbital Tablets USP recalled over labeling errors
- Recall date
- April 20, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- C. O. Truxton recalls Phenobarbital Tablets USP, 60 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown…
- Recall number
- D-1113-2017
- FDA classification
- Class II
- Brand / firm
- C. O. Truxton
- Sold / distributed
- Nationwide
Why it was recalled
Labeling: Label Mixup; potentially mislabeled
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Phenobarbital Tablets USP, 60 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6151-10
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