Drug 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.
D-0308-2015
Product summary
- Event
- Event 69184
- Status
- Terminated
- Classification
- Class I
- Quantity
- 50 bottles
- Official record key
drug-enforcement:D-0308-2015
Official wording
Reason: Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Code information: Lot #: 05202014@3, Exp 11/16/2014
Distribution pattern: Directly to patients and physicians in FL, NJ, NY, and Puerto Rico
Derived failure modes
-
Unknown
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.