Recalls / Class II

Class IID-0269-2017

Product

Lipo-C (Methionine 25 mg/Inositol 50 mg/Choline Chloride 50 mg/Carnitine (L) 100 mg/Methylcobalamin 1 mg/Thiamine HCL 50 mg/Rivoflavin-5-Phosphate Sod 5 mg/Niacinamide 50 mg/Dexpanthenol 5 mg/Pyridoxine HCL 1.25 mg/Lidocaine HCL 10 mg/mL), (30 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): 07282016B (12/31/2016), 08242016B (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

69 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-0269-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.