The Recall Desk

FDA (Drugs) recall action 69945

K C Pharmaceuticals Inc recalled 4 products on 2014-12-31

The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2014-12-31
Critical
0
Units
1,553,832

Why these products were recalled

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • ModerateFDA (Drugs)··2014-12-31

    KC Pharmaceuticals Recalls Eye Drops Due to Non-GMP API Storage

    KC Pharmaceuticals is recalling 302,976 bottles of Eye Drops A.C. because the active ingredient was stored in a non-GMP compliant warehouse in Italy.

    Product
    Eye Drops A.C. (Tetrahydrozoline HCl 0.05%, Zinc sulfate 0.25%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Astringent Redness Reliever, Distributed by Safeway Inc., P.O. Box 99, Pleasanton, CA 94566-0009, UPC: 3 21130 70067 8; b) Best Choice, Distributed By: Valu
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2014-12-31

    KC Pharmaceuticals Recalls Sunmark Eye Drops for CGMP Deviations

    KC Pharmaceuticals is recalling Sunmark Eye Drops Advanced Moisturizer/Lubricant because the active ingredient was stored in a non-GMP compliant warehouse in Italy.

    Product
    SUNMARK EYE DROPS ADVANCED MOISTURIZER/LUBRICANT (DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE)
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2014-12-31

    Sunmark Eye Drops Recalled for Non-GMP API Storage

    K C Pharmaceuticals is recalling Sunmark Eye Drops because the active ingredient was stored in a non-GMP compliant warehouse in Italy.

    Product
    SUNMARK EYE DROPS ORIGINAL FORMULA (TETRAHYDROZOLINE HCL)
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2014-12-31

    K C Pharmaceuticals Recalls Eye Drops Due to Warehouse Storage Issues

    K C Pharmaceuticals is recalling specific lots of Eye Drops Industrial Strength because the active ingredient was stored in a non-GMP compliant warehouse in Italy.

    Product
    Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Manufactured for: Petragon, Inc., Edwardsville, KS 66111; b) SWIFT, Distributed by Swift First Aid, Inc., Valencia, Calif. 91355, UPC:
    Category
    Distribution
    0 states