Recalls / Class II
Class IID-1528-2015
Product
HCG 2,500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
- Affected lot / code info
- All lots distributed between November 2014 and May 2015; 03312015@18, 5/30/2015; 03252015@49, 5/24/2015; 04012015@60 5/31/2015; 05112015@59, 7/10/2015; 04062015@39, 6/5/2015; 04072015@25, 6/6/2015; 04072015@74, 6/6/2015; 04142015@44, 6/13/2015; 04172015@72, 6/16/2015; 04172015@77, 6/16/2015; 04232015@8, 6/22/2015; 04222015@60, 6/21/2015; 04242015@11, 6/23/2015; 04292015@33, 6/28/2015
Why it was recalled
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recalling firm
- Firm
- The Compounding Pharmacy of America
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 6216 Highland Place Way Ste 101-A, Knoxville, Tennessee 37919-4068
Distribution
- Quantity
- 99 ml total
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-06-02
- FDA classified
- 2015-09-15
- Posted by FDA
- 2015-09-23
- Terminated
- 2016-02-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1528-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.