D-666-2013 Class II Terminated

Recalled by Clinical Specialties Compounding Pharmacy — Augusta, GA

FDA drug recall D-666-2013 was initiated by Clinical Specialties Compounding Pharmacy on March 20, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes The recall status is terminated (terminated February 22, 2017). Affected quantity: unknown.

Recall Details

Product Type
Drugs
Report Date
July 10, 2013
Initiation Date
March 20, 2013
Termination Date
February 22, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
unknown

Product Description

Test Cyp 200 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907

Reason for Recall

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

Distribution Pattern

FL, GA and SC.

Code Information

Lot number CABCBJBA:26, Exp date: 4/17/2013; Lot number CABCBEBB:55, Exp date: 5/13/2013; Lot number CABCBEBB:75, Exp date: 5/13/2013; Lot number CABCCBBC:96, Exp date: 6/19/2013; Lot number CABCCHBC:80, Exp date: 6/25/2013; Lot number CABDAJAB:88, Exp date: 7/8/2013; Lot number CABDAEAB:41, Exp date: 7/3/2013; Lot number CABDBBAB:23, Exp date: 7/10/2013; Lot number CABDBHAB:14, Exp date: 7/16/2013; Lot number CABDCEAB:13, Exp date: 7/23/2013; Lot number CABDCFAB:33, Exp date: 7/24/2013 and Lot number CABDABAD:38, Exp date: 8/28/2013.