Home / Recalls / The Apothecary Shoppe LLC / D-1309-2015

D-1309-2015 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
75 mL

Product Description

SIU-Tri-Mix 30/2/20 Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1398-47

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 #s: 04082015@45, BUD 9/1/2015; 04162015@28, BUD 10/13/2015; 03182015@9, BUD 7/16/2015

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-1303-2015 Class II — SIU-Tri-Mix 18/1/20 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compoundi (June 26, 2015)
  • D-1293-2015 Class II — SIH-Testosterone Cyp. 20 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe (June 26, 2015)
  • D-1310-2015 Class II — SIU-Tri-Mix 24 mg/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compou (June 26, 2015)
  • D-1290-2015 Class II — S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 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-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)