FDA recall D-1071-2014

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.

Reason for recall

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.

Distribution

Nationwide and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2013-09-09

Report date

2014-02-12

Termination date

2014-04-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Buffalo Grove, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1071-2014