Recalls / Class II
Class IID-0276-2017
Product
MIC Ultra Cocktail (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50mg/Methylcobalamin 700mcg/Chromium Picolinate 20 mcg/Pyridoxine HCL 2mg/ml), (10 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): 06132016B (11/30/2016), 08042016B (12/31/2016), 08252016A (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
- 278 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-0276-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.