Ropivacaine HCL (PF) 0.2% (2mg/mL) 100 mL Cassette Rx Only Banner Health Compounding Pharmacy 73...

FDA Recall #D-0024-2018 — Class II — October 10, 2017

Recall #D-0024-2018 Date: October 10, 2017 Classification: Class II Status: Terminated

Product Description

Ropivacaine HCL (PF) 0.2% (2mg/mL) 100 mL Cassette Rx Only Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226 NDC 7025006301

Reason for Recall

Lack of Assurance of Sterility.

Recalling Firm

Banner Pharmacy Services, LLC — Chandler, AZ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

2173 cassettes

Distribution

Nationwide within the US

Code Information

Lot #: 041117S2, Exp 10/11/2017; 041817S3, Exp 10/18/2017; 042517S3, 10/25/2017; 050117S2, Exp 10/3102/17; 053017S3, Exp 11/29/2017; 060117S3, Exp 12/1/2017; 060617S3, Exp 12/6/2017; 061217S1, 12/12/2017; 062017S3, Exp 12/20/2017; 062717S2, Exp 12/27/2017; 062817S3, Exp 12/28/2017; 071117S2, Exp 1/10/2018; 071817S3, Exp 1/17/2018; 072117S3, Exp 1/20/2018; 072417S3, Exp 1/23/2018; 072517S3, Exp 1/24/2018; 080217S4, Exp 2/1/2018; 081117S3, Exp 2/10/2018; 081817S2, Exp 2/17/2018; 082317S4, Exp 2/22/2018.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated