Product Detail

Product Description Gentamicin buffered 36.4 mg/ml, Clinical Specialties
Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907

Recall Number D-642-2013

Classification Class II

Code Info Lot number CABCAFBB:81, Exp date: 5/4/2013; Lot number
CABCCEAJ:85 Exp date: 3/23/2013 and Lot number CABDCFAC:25 Exp date: 8/24/2013.

Product Distributed Qty 35ml total

Reason For Recall Lack of Assurance of Sterility: FDA inspection findings
resulted in concerns regarding quality control processes

Event Detail

Event Id 64661

Product Type Drugs

Status Ongoing

Recalling Firm
Clinical Specialties Compounding Pharmacy

City Augusta
State GA
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-03-20

Initial Firm Notification of Consignee or Public Telephone

Distribution Pattern FL, GA and SC.