Home / Recalls / Oregon Compounding Centers, Inc. dba Creative Compounds / D-0208-2015

D-0208-2015 Class II Terminated

Recalled by Oregon Compounding Centers, Inc. dba Creative Compounds — Wilsonville, OR

Recall Details

Product Type
Drugs
Report Date
November 12, 2014
Initiation Date
October 6, 2014
Termination Date
June 30, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
680 mL

Product Description

OMNIPAQUE, 300mgI/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

Reason for Recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Distribution Pattern

Oregon, Washington

Code Information

Lot #: 20140711@1, discard date: 1/7/2015; Lot #: 20140814@22, discard date: 2/10/2015; Lot #: 20140815@13, discard date: 2/11/2015.

Other recalls by Oregon Compounding Centers, Inc. dba Creative Compounds

  • D-0198-2015 Class II — HYDROXOCOBALAMIN-preservative free (B12), 1mg/mL, injectable, 2 mL glass vial, R (October 6, 2014)
  • D-0221-2015 Class II — PYRIDOXINE HCL, with preservative, 100 mg/mL, injectable, 30 mL glass vial, RX, (October 6, 2014)
  • D-0175-2015 Class II — ASCORBIC ACID (B), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compo (October 6, 2014)
  • D-0191-2015 Class II — GANCICLOVIR, preservative free, 0.2mg/0.05mL, injectable, 0.1 mL plastic syringe (October 6, 2014)
  • D-0193-2015 Class II — GENTAMICIN SULFATE, 480mg/1000mL, solution for irrigation, 300 mL plastic bottle (October 6, 2014)
  • D-0204-2015 Class II — METHYCOBALAMIN, preservative free, 20mg/mL, injectable, 0.3 mL or 1 mL glass via (October 6, 2014)
  • D-0176-2015 Class II — ASCORBIC ACID (with Preservative), 500 mg/mL, injectable, 100 mL glass vial, RX, (October 6, 2014)
  • D-0223-2015 Class II — TESTOSTERONE CYPIONATE (GRAPE SEED OIL/COMPOUNDED), 200mg/mL, injectable, 5 mL g (October 6, 2014)
  • D-0216-2015 Class II — PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.16mg/0.57mg/19.45mcg, injectable, 1.7 (October 6, 2014)
  • D-0213-2015 Class II — PAPAVERINE HCL/PHENTOLAMINE MES/PROSTAGLANDIN, 23mg/0. 96mg/19.23mcg, injectable (October 6, 2014)