drugs Class III Updated 2014-02-12

PACK Pharmaceuticals, LLC recalls Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 5mL,

Recalled 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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #:NDW3065,NDW3066,NDW3067,NDW3068,NDW3069. Exp.05/15.
View official government recall

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