Recalls / Class II

Class IID-666-2013

Product

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

Affected lot / code info

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.

Why it was recalled

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

Recalling firm

Firm

Clinical Specialties Compounding Pharmacy

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

318 Baston Rd, N/A, Augusta, Georgia 30907

Distribution

Quantity

unknown

Distribution pattern

FL, GA and SC.

Timeline

Recall initiated

2013-03-20

FDA classified

2013-07-03

Posted by FDA

2013-07-10

Terminated

2017-02-22

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-666-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.