The Recall Desk

FDA (Drugs) recall action 66595

PACK Pharmaceuticals, LLC recalled 6 products on 2014-02-12

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
2014-02-12
Critical
0
Units
160,221

Why these products were recalled

Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.

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.

States named across these recalls

1–6 of 6

  • LowFDA (Drugs)··2014-02-12

    PACK Pharmaceuticals Recalls Timolol Maleate Eye Drops Due to Container Defects

    PACK Pharmaceuticals is recalling specific lots of Timolol Maleate eye drops because stability samples showed white solid residue on the exterior of the bottles.

    Product
    Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 5mL, (NDC 16571-140-50). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.
    Category
    Distribution
    1 state
  • LowFDA (Drugs)··2014-02-12

    Timolol Maleate Eye Drops Recalled for Exterior Bottle Residue

    PACK Pharmaceuticals is recalling Timolol Maleate eye drops due to white solid residue found on the exterior of the bottles.

    Product
    Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 5mL, (NDC 16571-141-50). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.
    Category
    Distribution
    1 state
  • LowFDA (Drugs)··2014-02-12

    Timolol Maleate Eye Drops Recalled Due to Exterior Residue

    PACK Pharmaceuticals is recalling Timolol Maleate Sterile Ophthalmic Solution due to white solid residue found on the exterior of the bottles.

    Product
    Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 10mL, (NDC 16571-140-10). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.
    Category
    Distribution
    1 state
  • LowFDA (Drugs)··2014-02-12

    PACK Pharmaceuticals Recalls Timolol Maleate Eye Drops Due to Exterior Residue

    PACK Pharmaceuticals is recalling Timolol Maleate Sterile Ophthalmic Solution due to white solid residue found on the exterior of bottles.

    Product
    Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 10mL, (NDC 16571-141-10). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.
    Category
    Distribution
    1 state
  • LowFDA (Drugs)··2014-02-12

    PACK Pharmaceuticals Recalls Ofloxacin Ophthalmic Solution Due to Container Defects

    PACK Pharmaceuticals is recalling 126 bottles of Ofloxacin Ophthalmic Solution 0.3% because stability samples showed white solid residue on the exterior of the bottles.

    Product
    Ofloxacin Ophthalmic Solution, USP 0.3%, 10mL, (NDC 16571-130-11). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.
    Category
    Distribution
    1 state
  • LowFDA (Drugs)··2014-02-12

    PACK Pharmaceuticals Recalls Ofloxacin Ophthalmic Solution Due to Container Defects

    PACK Pharmaceuticals is recalling 32,029 bottles of Ofloxacin Ophthalmic Solution because stability samples showed white solid residue on the exterior of the bottles.

    Product
    Ofloxacin Ophthalmic Solution, USP 0.3%, 5mL, (NDC 16571-130-50). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.
    Category
    Distribution
    1 state