PlainRecalls
FDA Drug Moderate Class II Terminated

Methylcobalamin 25,000 mcg/ml Intramuscular, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Reported: September 23, 2015 Initiated: June 2, 2015 #D-1573-2015

Product Description

Methylcobalamin 25,000 mcg/ml Intramuscular, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Reason for Recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Details

Units Affected
99 ml total
Distribution
Nationwide
Location
Knoxville, TN

Frequently Asked Questions

What product was recalled?
Methylcobalamin 25,000 mcg/ml Intramuscular, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN. Recalled by The Compounding Pharmacy of America. Units affected: 99 ml total.
Why was this product recalled?
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on September 23, 2015. Severity: Moderate. Recall number: D-1573-2015.