FDA recall D-0308-2015

Product

Tropi/Cyclo/Phenyl/Tobra/Flurb (1/1/10/0.3/0.03)% Sterile Ophthalmic Solution, 1 mL Dropper in a 3 mL bottle, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.

Reason for recall

Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.

Distribution

Directly to patients and physicians in FL, NJ, NY, and Puerto Rico

Key facts

Status

Terminated

Initiation date

2014-09-05

Report date

2014-12-31

Termination date

2015-07-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Randolph, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0308-2015