Home / Recalls / Oregon Compounding Centers, Inc. dba Creative Compounds / D-0195-2015

D-0195-2015 Class II Terminated

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

FDA drug recall D-0195-2015 was initiated by Oregon Compounding Centers, Inc. dba Creative Compounds on October 6, 2014 and is designated Class II. 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 st… The recall status is terminated (terminated June 30, 2015). Affected quantity: 2200 mL.

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
2200 mL

Product Description

GLUTATHIONE with preservative, 100mg/mL, injectable, 100 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 #: 20140721@25/00, discard date: 11/18/2014; Lot #: 20140902@47, discard date: 12/31/2014.

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

  • D-0176-2015 Class II — ASCORBIC ACID (with Preservative), 500 mg/mL, injectable, 100 mL glass vial, RX, (October 6, 2014)
  • D-0213-2015 Class II — PAPAVERINE HCL/PHENTOLAMINE MES/PROSTAGLANDIN, 23mg/0. 96mg/19.23mcg, injectable (October 6, 2014)
  • 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-0197-2015 Class II — HYALURONIDASE, 240 u/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wi (October 6, 2014)
  • D-0179-2015 Class II — CALCIUM CHLORIDE (COMPOUND), 100 mg/mL, Injectable, 10 mL glass vial, RX, Creati (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)

FDA data resources