Home / Recalls / The Apothecary Shoppe LLC / D-1314-2015

D-1314-2015 Class II Terminated

Recalled by The Apothecary Shoppe LLC — Tulsa, OK

Recall Details

Product Type
Drugs
Report Date
August 12, 2015
Initiation Date
June 26, 2015
Termination Date
February 17, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10 mL

Product Description

SIU-Phentolamine 5 mg/mL in Normal Saline, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135

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.

Distribution Pattern

Oklahoma

Code Information

Lot #: 03102015@42, BUD 09/06/2015

Other recalls by The Apothecary Shoppe LLC

  • 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-1294-2015 Class II — SIU-Papaverine 30 mg/mL Inj., Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding (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-1308-2015 Class II — SIU-Tri-Mix 30/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compoundi (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-1301-2015 Class II — SIU-Prostaglandin E1 20 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe (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-1311-2015 Class II — SIU-Tri-Mix 30/1/20 Injectable, Rx Only, 10 mL Vial, Apothecary Shoppe, Compound (June 26, 2015)