Recalls / Class II
Class IID-1505-2015
Product
HCG 1,000 IU/ml + Methylcobalamin 0.05 mg/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; 04152015@15, 6/14/2015; 03232015@64, 5/22/2015; 04222015@68, 6/21/2015; 04272015@86, 6/26/2015; 04292015@62, 6/28/2015; 05062015@5, 7/5/2015
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
- 3120 ml total volume
- 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-1505-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.