FDA Recall D-0600-2018
The Compounding Pharmacy of America · Knoxville, TN
Class I — life-threatening Terminated 1125 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, Sterile, Rx Only, Compounded by The Compounding Pharmacy of America, 6216 Highland Place Way, Ste. 101A Knoxville, TN 37919 Ph (855) 277-2488 Fax (888) 689-9892
Reason for recall
Non-Sterility
Recall record
- Recall number
D-0600-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- TN, SC
- Recall initiated
- 2018-01-12
- Classified by FDA Center
- 2018-03-14
- FDA published
- 2018-02-21
- Terminated
- 2021-02-10
- Recalling firm
- The Compounding Pharmacy of America
- Firm location
- Knoxville, TN