HCG, Human chorionic gonadotropin 11,000 units, injection, Rx Only, Promise Pharmacy Compounding ...
FDA Recall #D-0460-2019 — Class II — December 17, 2018
Product Description
HCG, Human chorionic gonadotropin 11,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Reason for Recall
Lack of sterility assurance.
Recalling Firm
Promise Pharmacy, LLC — Palm Harbor, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
654 vials
Distribution
Nationwide in the USA.
Code Information
Lots: 06182018@5 BUD: 12/15/2018; 07102018@5 BUD: 1/6/2018; 08212018@8 BUD: 2/17/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated