D-1308-2015 Class II Terminated

Recalled by The Apothecary Shoppe LLC — Tulsa, OK

Recall Details

SIU-Tri-Mix 30/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-2196-10

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Oklahoma

Lot #s: 04162015@41, BUD: 10/13/2015; 03122015@42, BUD: 7/10/2015

D-0002-2017 Class II — Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials, I (September 12, 2016)
D-0004-2017 Class II — Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) pa (September 12, 2016)
D-0003-2017 Class II — Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, IM, (September 12, 2016)
D-1299-2015 Class II — SIU-Papav/Phentol 30/.5 mg/mL Injection, Rx Only, 3 mL Vial, Apothecary Shoppe, (June 26, 2015)
D-1298-2015 Class II — SIU-Papav/Phent 30/1 mg Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compoundin (June 26, 2015)
D-1311-2015 Class II — SIU-Tri-Mix 30/1/20 Injectable, Rx Only, 10 mL Vial, Apothecary Shoppe, Compound (June 26, 2015)
D-1295-2015 Class II — SIU-Papav/Phent 24/1 mg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compoun (June 26, 2015)
D-1300-2015 Class II — SIU-Phent .8/PGE1 20 mcg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compou (June 26, 2015)
D-1294-2015 Class II — SIU-Papaverine 30 mg/mL Inj., Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding (June 26, 2015)
D-1301-2015 Class II — SIU-Prostaglandin E1 20 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe (June 26, 2015)