November 2018 FDA Recall Drug by Pharm D Solutions, Llc
D-0343-2019 - Lack of Assurance of Sterility
This Class II drug recall was voluntarily initiated by Pharm D Solutions, Llc on November 19, 2018 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in WA and the recall is currently terminated.
Recall Number: D-0343-2019
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
11-19-2018
12-26-2018
85 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
WA
10-13-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054 1-844-263-6843 --- NDC: 69699-1738-10
Batch or Lot Expiration Information
Lot# Lot: 10292018:21 Exp. 3/31/2019
