HCG 5,000 IU Vial. Compounded by Tri-Coast Pharmacy.
FDA Recall #D-0261-2017 — Class II — November 17, 2016
Product Description
HCG 5,000 IU 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
4,884 vials
Distribution
Nationwide
Code Information
Lot codes: 06222016D, 06062016C, 07192016C07062016A, 08182016B, 08112016A, 08012016A, 09282016A, 09122016D, 10182016C, 11042016B, 11012016F; Exp. 11/16
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated