SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary Shoppe, Compounding Pharmacy, Tulsa, OK 74135, NDC 13452-2774-94
Recall Number: D-1312-2015
Firm: The Apothecary Shoppe LLC
Classification: Class II
Status: Terminated
Report Date: 20150812
Initiation Date: 20150626
Termination Date: 20170217
Reason for Recall
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Product Description
SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary Shoppe, Compounding Pharmacy, Tulsa, OK 74135, NDC 13452-2774-94