FDA-Drug2014-02-12Class III
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.
PACK Pharmaceuticals, LLC
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.
Sold states
Nationwide and Puerto Rico.
Affected count
3,415 bottles
Manufactured in
1110 W Lake Cook Rd, Ste 301, Buffalo Grove, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1070-2014Don't want to check this manually?
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