March 2013 FDA Recall Drug by Clinical Specialties Compounding Pharmacy
D-918-2013 - Lack of Assurance of Sterility; product linked to adverse event reports of endophthalimitis eye infections and FDA inspection findings resulted in concerns regarding quality control processes

This Class II drug recall was voluntarily initiated by Clinical Specialties Compounding Pharmacy on March 11, 2013 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility; product linked to adverse event reports of endophthalimitis eye infections and fda inspection findings resulted in concerns regarding quality control processes. The product was distributed in FL, GA, IN, LA and SC. and the recall is currently terminated.

Recall Number: D-918-2013

Reason for Recall
Lack of Assurance of Sterility; product linked to adverse event reports of endophthalimitis eye infections and FDA inspection findings resulted in concerns regarding quality control processes
Initiated
03-11-2013
Reported
09-04-2013
Quantity
2190 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65253
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Clinical Specialties Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, IN, LA and SC.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-22-2017
Product Description About Product Description
Full technical description of the product.
Avastin, (0.05 ml, 1.25 mg/0.05ml), single unit dose syringes, Clinical Specialties Compounding Pharmacy, Augusta, GA

Batch or Lot Expiration Information

Lot# CABDAHAC:39, Exp. Date: 5/8/2013
Lot# CABDAGAC:58, Exp. Date: 4/13/2013
Lot# CABDAHAC:77, Exp. Date: 4/8/2013
Lot# CABDBIAC:86, Exp. Date: 4/19/2013
Lot# CABDCFAC:29, Exp. Date: 4/26/2013
Lot# CABDAEAD:26, Exp. Date: 5/3/2013
Lot# CABDAEAC:47, Exp. Date: 5/5/2013
Lot# CABDAEAC:58, Exp. Date: 5/5/2013
Lot# CABDAFAC:46, Exp. Date: 5/6/2013
Lot# CABDAIAC:46, Exp. Date: 5/9/2013
Lot# CABDBCAC:94, Exp. Date: 5/13/2013
Lot# CABDCCAC:26, Exp. Date: 5/23/2013
Lot# CABDCFAC:81, Exp. Date: 5/26/2013
Lot# CABDABAD:05, Exp. Date: 5/30/2013
Lot# CABDAFAC:47, Exp. Date: 5/6/2013
Lot# CABDAGAC:43, Exp. Date: 5/7/2013
Lot# CABDBDAC:69, Exp. Date: 5/14/2013
Lot# CABDBIAC:77, Exp. Date: 5/19/2013
Lot# CABDCHAC:19, Exp. Date: 5/28/2013
Lot# CABDAHAD:21, Exp. Date: 6/5/2013
Lot# CABDCFAC:17, Exp. Date: 5/26/2013
Lot# CABDAHAD:00, Exp. Date: 6/5/2013
Lot# CABDBCAC:47, Exp. Date: 5/13/2013
Lot# CABDCBAC:97, Exp. Date: 5/22/2013
Lot# CABDAGAC:08, Exp. Date: 5/7/2013
Lot# CABDBCAC:15, Exp. Date : 5/13/2013
Lot# CABDBDAC:17, Exp. Date: 5/14/2013
Lot# CABDCIAC:42, Exp. Date : 5/29/2013
Lot# CABDBEAC:44, Exp. Date: 5/15/2013
Lot# CABDCBAC:79, Exp. Date: 5/22/2013
Lot# CABDCIAC:00, Exp. Date : 5/29/2013
Lot# CABDAHAD:82, Exp. Date : 6/5/2013
Lot# CABDCBAC:31, Exp. Date: 5/22/2013
Lot# CABDCIAB:68, Exp. Date: 4/28/2013
Lot# CABDCJAB:59, Exp. Date: 4/29/2013
Lot# CABDDBAB:93, Exp. Date: 5/1/2013
Lot# CABCCGBC:92, Exp. Date: 2/24/2013
Lot# CABCCGBC:49, Exp. Date: 3/26/2013
Lot# CABCCIBC:39, Exp. Date: 3/23/2013
Lot# CABCDBBC:71, Exp. Date: 3/1/2013
Lot# CABDACAB:56, Exp. Date: 4/2/2013
Lot# CABDACAB:76, Exp. Date: 4/2/2013
Lot# CABDACAB:89, Exp. Date: 4/2/2013
Lot# CABDADAB:69, Exp. Date: 4/3/2013
Lot# CABDADAB:93, Exp. Date: 4/3/2013
Lot# CABDADAB:54, Exp. Date: 4/3/2013
Lot# CABDAEAB:96, Exp. Date: 4/4/2013
Lot# CABDAHAB:00, Exp. Date: 4/7/2013
Lot# CABDAHAB:59, Exp. Date: 4/7/2013
Lot# CABDAHAB:18, Exp. Date: 4/7/2013
Lot# CABDAJAB:30, Exp. Date: 4/9/2013
Lot# CABDAJAB:70, Exp. Date: 4/9/2013
Lot# CABDAJAB:97, Exp. Date: 4/9/2013
Lot# CABDBAAB:63, Exp. Date: 4/10/2013
Lot# CABDBAAB:77, Exp. Date: 4/10/2013
Lot# CABDBAAB:54, Exp. Date: 4/10/2013
Lot# CABDBAAB:04, Exp. Date: 4/10/2013
Lot# CABDBEAB:97, Exp. Date: 4/14/2013
Lot# CABDBFAB:67, Exp. Date: 3/16/2013
Lot# CABDBFAB:61, Exp. Date: 4/15/2013
Lot# CABDBFAB:84, Exp. Date: 4/15/2013
Lot# CABDBGAB:34, Exp. Date: 4/16/2013
Lot# CABDBHAB:33, Exp. Date: 4/17/2013
Lot# CABDBHAB:71, Exp. Date: 4/17/2013
Lot# CABDBHAB:75, Exp. Date: 4/17/2013
Lot# CABDCBAB:66, Exp. Date: 4/21/2013
Lot# CABDCCAB:64, Exp. Date: 4/22/2013
Lot# CABDCDAB:38, Exp. Date: 4/23/2013
Lot# CABDCEAB:71, Exp. Date: 4/24/2013
Lot# CABDCEAB:04, Exp. Date: 4/24/2013
Lot# CABDCFAB:22, Exp. Date: 3/26/2013
Lot# CABDCFAB:14, Exp. Date: 4/25/2013
Lot# CABDCIAB:51, Exp. Date: 4/28/2013
Lot# CABDCIAB:93, Exp. Date: 3/29/2013
Lot# CABDDBAB:71, Exp. Date: 4/1/2013
Lot# CABCBJBC:00, Exp. Date: 3/19/2013
Lot# CABCCGBC:30, Exp. Date: 3/26/2013
Lot# CABCCHBC:55, Exp. Date: 3/27/2013 and
Lot# CABCDBBC:87, Exp. Date: 3/31/2013