Recalls / Class II
Class IID-636-2013
Product
Cyclosporine 1% ophthalmic drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Affected lot / code info
- Lot number CABCBEBB:35, Exp date: 5/13/2013; Lot number CABACAB:76 Exp date: 7/1/2013; Lot number CABDAIAB:78, Exp date: 4/8/2013; Lot number CABDAEAC:80, Exp date: 5/5/2013 and Lot number CABDCCAC:31, 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
- 55 ml
- 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-636-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.