Recalls / Class II

Class IID-0323-2017

Product

Ultra Cocktail #2 (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25 mg/Methylcobalamin 300mcg/Carnitine (L) 170mg/Thiamine HCL 20mg/Riboflavin-5-Phosphate Sod 2mg/Pyridoxine HCL 2mg/Folic Acid 2mg/Ascorbic Acid 20mg/Chromium Picolinate 66mcg/Lidocaine HCL 10mg/mL), (30 ML and 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): 05192016A (11/15/2016), 08032016B (12/31/2016), 08232016A (12/31/2016), 09292016C (01/31/2017).

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

123 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-0323-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.