PACK Pharmaceuticals, LLC: 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.

Agency Publication Date: February 4, 2014

Affected Products

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.

Lot #:OW3061,OW3062. Exp. 05/15.

Lot Numbers:

OW3061

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.

Lot #:OW3071.Exp. 06/2015.

Lot Numbers:

OW3071

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.

Lot #: NW3061,NW3062. Exp. 05/15.

Lot Numbers:

NW3061

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.

Lot #:NW3071. Exp. 06/15.

Lot Numbers:

NW3071

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.

Lot #:NDW3065,NDW3066,NDW3067,NDW3068,NDW3069. Exp.05/15.

Lot Numbers:

NDW3065

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.

Lot #:NDW3071,NDW3072. Exp.06/15

Lot Numbers:

NDW3071

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 66595

Status: Resolved

Manufacturer: PACK Pharmaceuticals, LLC

Manufactured In: United States

Units Affected: 6 products (32,029 bottles; 126 bottles; 3,415 bottles; 78 bottles; 122,551 bottles; 2,022 bottles)

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Lot #:OW3061,OW3062. Exp. 05/15.

Lot Numbers:

OW3061

Lot #:OW3071.Exp. 06/2015.

Lot Numbers:

OW3071

Lot #: NW3061,NW3062. Exp. 05/15.

Lot Numbers:

NW3061

Lot #:NW3071. Exp. 06/15.

Lot Numbers:

NW3071

Lot #:NDW3065,NDW3066,NDW3067,NDW3068,NDW3069. Exp.05/15.

Lot Numbers:

NDW3065

Lot #:NDW3071,NDW3072. Exp.06/15

Lot Numbers:

NDW3071