April 2014 FDA Recall Drug by Ferring Pharmaceuticals Inc
D-1385-2014 - Chemical Contamination

This Class II drug recall was voluntarily initiated by Ferring Pharmaceuticals Inc on April 28, 2014 for the product Drug. The FDA reported the reason for recall as chemical contamination. The product was distributed in PA and the recall is currently terminated.

Recall Number: D-1385-2014

Reason for Recall
Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone oil due to leakage of a leaking line during the freeze-drying process.
Initiated
04-28-2014
Reported
06-25-2014
Quantity
129,060 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68407
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.
Ferring Pharmaceuticals 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
PA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-06-2015
Product Description About Product Description
Full technical description of the product.
TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bottle, Rx Only, Manufactured in Israel, Distributed by: Gate Pharmaceuticals div. of Teva Pharmaceuticals USA Sellersville,PA 18960. NDC 57844-713-46

Batch or Lot Expiration Information

Lot# H11599A; Exp. 03/16
Lot# H11599B; Exp. 03/16
Lot# H12913A; Exp. 05/16
Lot# H12913B; Exp. 05/16
Lot# H12914A; Exp. 05/16
Lot# H12914B; Exp. 05/16
Lot# H13846A; Exp. 07/16
Lot# H13846B; Exp. 07/16