PlainRecalls
FDA Drug Moderate Class II Terminated

LIDOCAINE HCL (REPKG-STERILE), 4%, solution for irrigation, 5 mL, 6 mL, and 7 mL plastic dropper bottle, RX, Creative Compounds, Wilsonville, OR 97070

Reported: November 12, 2014 Initiated: October 6, 2014 #D-0201-2015

Product Description

LIDOCAINE HCL (REPKG-STERILE), 4%, solution for irrigation, 5 mL, 6 mL, and 7 mL plastic dropper 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.

Details

Units Affected
49/5 mL bottles; 40/6 mL bottles; 30/7 ml bottles
Distribution
Oregon, Washington
Location
Wilsonville, OR

Frequently Asked Questions

What product was recalled?
LIDOCAINE HCL (REPKG-STERILE), 4%, solution for irrigation, 5 mL, 6 mL, and 7 mL plastic dropper bottle, RX, Creative Compounds, Wilsonville, OR 97070. Recalled by Oregon Compounding Centers, Inc. dba Creative Compounds. Units affected: 49/5 mL bottles; 40/6 mL bottles; 30/7 ml bottles.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 12, 2014. Severity: Moderate. Recall number: D-0201-2015.