Recalls / Class II
Class IID-675-2013
Product
Test Cyp 50 mg-estradiol cyp 2 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Affected lot / code info
- Lot number CABCACBA:23, Exp date: 3/31/2013 and Lot number CABDAIAD:13, Exp date: 9/4/2013.
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
- 13ml
- 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-675-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.