FDA Drug Class II — Moderate

Chorionic Gonadotropin, Lyophilized, 6,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Hazard

Lack of Assurance of Sterility

Products

Chorionic Gonadotropin, Lyophilized, 6,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Brand
Wells Pharmacy Network LLC
UPC
All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code:04212016@49, 05262016@154, 06092016@181, 08082016@118, 08252016@89. Known vial lot code: 04142016@34, 05202016@55, 06032016@42, 08012016@41, 08192016@47.

Units Affected

2,339 kits (number of vials per kit vary by prescription)