Recalls / Class II
Class IID-0246-2017
Product
Amino Energy Cocktail (30 ML), (Methionine (L) 12.5 mg/Inositol 25 mg/Choline Chloride 25 mg/Methylcobalamin 300 mcg/Carnitine (L) 125 mg/Thiamine HCL 50 mg/Riboflavin-5-Phosphate Sod 5 mg/Niacinamide 20 mg/Pyridoxine HCL 2 mg/Folic Acid 2 mg/Ascorbic Acid 50 mg/Chromium Picolinate 200 mcg/Glutamine (L) 30 mg/Lidocaine HCL 10 mg/mL). Compounded by Tri-Coast Pharmacy.
- Affected lot / code info
- Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06012016A (11/28/2016), 07282016A (12/31/2016).
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Tri-Coast Pharmacy
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 14125 US Highway 1, N/A, Juno Beach, Florida 33408-1425
Distribution
- Quantity
- 59 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-11-17
- FDA classified
- 2017-01-04
- Posted by FDA
- 2017-01-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0246-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.