FDA - MedWatch - Merck Recalls 3 Lots Of Invanz (ertapenem sodium) Injection Because The Product May Contain Broken Glass Pieces In The Reconstituted Solution For Injection

ROCKVILLE, Md., July 5, 2007-Merck and FDA informed healthcare professionals that 3 lots of Invanz (0803930, 0803940, and 0803950), a product indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated microorganisms, were recalled. The product was recalled because of two incidents of finding broken glass pieces in the reconstituted solution for injection. Healthcare professionals are advised to immediately stop dispensing all products from the three lots specified above. No other lots are affected by this recall.

Read the complete MedWatch 2007 Safety Summary including a link to the manufacturer's Dear Healthcare Professional Letter below:

Voluntary Recall INVANZ® (Ertapenem Sodium) 1g / NDC 0006-3843-71

Lot numbers 0803930, 0803940, 0803950 (exp. OCT-2008)

July 2, 2007

Dear Customer, Doctor, Healthcare Provider:

Merck & Co., Inc. has initiated a voluntary recall for three lots of INVANZ® (Ertapenem Sodium) 1g. The lots of INVANZ® that are being recalled are lot numbers 0803930, 0803940, 0803950. All lots have an expiry date of October 2008. No other lots are affected by this recall.

The company is taking this voluntary action as a precautionary measure due to the fact that we cannot exclude the possibility that glass pieces could be present in some vials of INVANZ® of the three recalled lots.

The company is working closely with the Food and Drug Administration to inform our direct customers of our decision. In addition, if you are a direct customer of Merck & Co., Inc. and have further distributed these lots of INVANZ®, please contact all accounts to the hospital level to ensure affected product is returned.

In order to ensure an effective and compliant return process, it is important that you do the following:

1. Immediately stop dispensing all product from the 3 lots identified above.

2. Please complete both the Business Reply Card and the Packing Slip including entry of physical count information.

3. Mail the postage paid Business Reply Card even if you do not have any of the product identified above to ensure accountability.

4. Return all of the product identified above and the Packing Slip using the prepaid Shipping Labels to:

Stericycle, Attn: Merck Returns

2670 Executive Drive, Suite A

Indianapolis, IN 46241

Merck & Co., Inc. has completed a comprehensive medical assessment to evaluate the potential impact of administration of INVANZ® that may contain glass particles. While we believe the incidence of INVANZ® vials that could contain glass particles is extremely low, in the event that a dose of INVANZ® was administered and did contain glass particles, the risk of associated medical harm is unlikely. If you have any medical questions, please contact Merck’s National Service Center at 1-800-672-6372.

We appreciate your immediate attention and cooperation and sincerely regret any inconvenience caused by this action.

Sincerely,

Dr. Elaine S. Perry

Merck & Co., Inc.

Medical Services

Posted: July 2007


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