March 2017 FDA Recall Drug by Isomeric Pharmacy Solution, Llc
D-0518-2017 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Isomeric Pharmacy Solution, Llc on March 8, 2017 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0518-2017

Reason for Recall
CGMP Deviations
Initiated
03-08-2017
Reported
03-22-2017
Quantity
6,999 single-use vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76676
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Isomeric Pharmacy Solution, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-25-2017
Product Description About Product Description
Full technical description of the product.
Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection, Preservative Free, Rx only, Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109, NDC 70285-1920-1

Batch or Lot Expiration Information

Lot# 08016; Exp. 03/14/17
Lot# 08018; Exp. 03/15/17
Lot# 08023; Exp. 03/22/17
Lot# 08026; Exp. 03/19/17
Lot# 08033; Exp. 03/28/17
Lot# 09004; Exp. 04/03/17
Lot# 11014; Exp. 06/10/17
Lot# 11031; Exp. 06/20/17