Home / Recalls / Oregon Compounding Centers, Inc. dba Creative Compounds / D-0194-2015

D-0194-2015 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
250 mL

Product Description

GLUTARALDEHYDE BUFFERED (POTASSIUM PHOSPHATE), solution for irrigation, 250 mL glass bottle, 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 #: 20140722@5, discard date: 10/20/2014; Lot #: 20140723@45, discard date: 10/21/2014.

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

  • 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-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-0174-2015 Class II — ALPROSTADIL/LIDOCAINE HCL, 20mcg/5mg/mL, 1.25 mL glass vial, RX, Creative Compo (October 6, 2014)