Product: PHENYLEPHRINE HCL IN BSS - P.F. OPHTHALMIC 1% INJECTABLE	35 ML;  PHENYLEPHRINE HCL, 1ML VIAL*** 1% (10MG/ML) INJECTABLE	1 ML  	10 ML  	  	25 ML  	  	5 ML  	  	50 ML;  PHENYLEPHRINE, STSL, P.F. (0.5ML SYRINGE, SLIP-TIP, NO NEEDLE) 1.25% INJECTABLE	5 ML  	  	  	  	7.5 ML  (8 DIFFERENT PRODUCTS)
Reason for recall: Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated: 20120521
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated