The Recall Desk

FDA (Drugs) recall action 77082

C. O. Truxton recalled 6 products on 2017-08-30

The FDA (Drugs) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2017-08-30
Critical
1
Units
—

Why these products were recalled

Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets

Labeling: Label Mixup; potentially mislabeled

The agency’s own wording, quoted from the enforcement report.

1–6 of 6

  • CriticalFDA (Drugs)··2017-08-30

    Phenobarbital Tablets Recalled Due to Incorrect Strength Labeling

    C. O. Truxton is recalling Phenobarbital 15 mg tablets that were actually 30 mg due to a labeling error.

    Product
    Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6160-10
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-08-30

    C. O. Truxton Recalls Phenobarbital Tablets Due to Labeling Error

    C. O. Truxton is recalling specific lots of Phenobarbital Tablets USP, 30 mg, because they may be mislabeled. The FDA classifies this as a Class I recall.

    Product
    Phenobarbital Tablets USP, 30 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6145-10
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2017-08-30

    C. O. Truxton Recalls Phenobarbital Tablets Due to Labeling Error

    C. O. Truxton is recalling specific lots of Phenobarbital Tablets USP, 60 mg, due to a label mixup that may result in mislabeling.

    Product
    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
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2017-08-30

    Phenobarbital Tablets Recalled for Potential Labeling Errors

    C. O. Truxton is recalling Phenobarbital Tablets USP, 100 mg, due to a label mixup that may result in mislabeled products.

    Product
    Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b) 1000 count bottles (NDC 0163-6152-10), Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2017-08-30

    C. O. Truxton Recalls Mislabeled Amitriptyline HCL Tablets

    C. O. Truxton is recalling specific lots of Amitriptyline HCL 50 mg tablets due to potential label mixups. The recall is nationwide.

    Product
    Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811, Distributed by: Truxton, Inc. Bellmawr, NJ 08031, NDC: 0463-6352-10
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2017-08-30

    C. O. Truxton Recalls Phenobarbital Tablets Due to Labeling Error

    C. O. Truxton is recalling specific lots of Phenobarbital Tablets USP, 15 mg, due to a label mixup that may result in mislabeled products.

    Product
    Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6160-10
    Category
    Distribution
    0 states