HCG/Hydroxycobalamin 5,000 IU/5 mg Vial. Compounded by Tri-Coast Pharmacy
FDA Recall #D-0262-2017 — Class II — November 17, 2016
Product Description
HCG/Hydroxycobalamin 5,000 IU/5 mg Vial. Compounded by Tri-Coast Pharmacy
Reason for Recall
Lack of Assurance of Sterility
Recalling Firm
Tri-Coast Pharmacy — Juno Beach, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1,304 vials
Distribution
Nationwide
Code Information
Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06232016A (12/20/2016), 07192016B (01/15/2017), 08262016A (01/31/2017), 08092016C (01/31/2017), 09192016C (01/31/2017), 11042016C (11/04/2016), 10252016A (02/28/2017)
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated