PACK Pharmaceuticals, LLC recalls Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 5mL, (NDC 16571-141-50). The products are packaged in Low Den
Recalled February 12, 2014 · FDA recall D-1072-2014 · PACK Pharmaceuticals
Hazard
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. · FDA Class III
Units
122,551 bottles
Sold at
Nationwide and Puerto Rico.
Description
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.
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.
Manufacturer(s)
PACK Pharmaceuticals, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →