August 2015 FDA Recall Drug by Eagle Pharmacy, Inc.
D-1832-2015 - Subpotent Drug

This Class II drug recall was voluntarily initiated by Eagle Pharmacy, Inc. on August 28, 2015 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed in TN, AL and the recall is currently terminated.

Recall Number: D-1832-2015

Reason for Recall
Subpotent Drug: trace amounts of methylcobalamin in compounded drug.
Initiated
08-28-2015
Reported
10-07-2015
Quantity
104 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72101
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.
Eagle Pharmacy, Inc.
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
TN, AL
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2015
Product Description About Product Description
Full technical description of the product.
LIPO B STERILE INJECTION 10 mL ( Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine Hydrochloride 5 mg, Methylcobalamin 0.1mg, Benzyl Alcohol, Sterile Water, Sodium Hydroxide, Hydrochloric Acid), Multidose vial, Rx Only, Compounded by Eagle Pharmacy, Birmingham, AL 35244

Batch or Lot Expiration Information

Lot# 07072015LIPO; Exp. 12/15