D-0308-2015 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 31, 2014
- Initiation Date
- September 5, 2014
- Termination Date
- July 6, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 bottles
Product Description
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 Pattern
Directly to patients and physicians in FL, NJ, NY, and Puerto Rico
Code Information
Lot #: 05202014@3, Exp 11/16/2014