Recalls / Class II

Class IID-637-2013

Product

Cyclosporine 2% ophthalmic, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907

Affected lot / code info

Lot number CABCCIBC:89, Exp date: 3/28/2013; Lot number CABDBEAB:07, Exp date: 4/14/2013; Lot number CABDCIAB:42, Exp date: 4/28/2013 and Lot number CABDCCAC:37, Exp date: 5/23/2013.

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

87 ml 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-637-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.