D-669-2013 Class II Terminated

Recalled by Clinical Specialties Compounding Pharmacy — Augusta, GA

FDA drug recall D-669-2013 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: 10ml total.

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
10ml total

Product Description

Test Cyp 250 mg-lidocaine 5 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 CABCCABB:74, Exp date: 5/19/2013 and Lot number CABCCABB:31 Exp date: 7/29/2013.