September 2017 FDA Recall Drug by United Pharmacy
D-0008-2018 - CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed

This Class II drug recall was voluntarily initiated by United Pharmacy on September 27, 2017 for the product Drug. The FDA reported the reason for recall as cgmp deviations; fda analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0008-2018

Reason for Recall
CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed
Initiated
09-27-2017
Reported
10-18-2017
Quantity
268 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78183
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.
United Pharmacy
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.
03-29-2018
Product Description About Product Description
Full technical description of the product.
Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For Injection, United Pharmacy Compounded, 13951 N. Haverhill Rd Ste. 120-121 West Palm Beach, FL 33417

Batch or Lot Expiration Information

Lot# Lot: GAC-12 BUD 11/10/17; Lot: GAC-13 BUD: 01/14/18