July 2018 FDA Recall Admelog by Sanofi-aventis U.s. Llc
D-0925-2018 - Temperature Abuse
This Class II drug recall was voluntarily initiated by Sanofi-aventis U.s. Llc on July 5, 2018 for the product Admelog. The FDA reported the reason for recall as temperature abuse. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0925-2018
Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
07-05-2018
07-18-2018
3214 prefilled pens
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Sanofi-Aventis U.S. 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Physician Sample - Not For Sale, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807, NDC 0024-5925-00
Batch or Lot Expiration Information
Lot# : 7F021B, Exp 6/30/20
