Recalls / Class II

Class IID-660-2013

Product

Pap 300 mg-phent 10 mg-prost 100 mcg, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907

Affected lot / code info

Lot number CABDBFAC:52, Exp date: 5/16/2013; Lot number CABDBBAB:40, Exp date: 4/11/2013; Lot number CABDCAAC:15, Exp date: 5/21/2013; Lot number CABDCCAC:75, Exp date: 5/23/2013 and Lot number CABDAFAD:77, Exp date: 6/3/2013.

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

96ml total

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-660-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.