Recall of one batch of RAN-Gabapentin 100 mg capsules due to cross-contamination with Etodolac

Starting date:

April 10, 2015

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Dosage

Audience:

General Public

Identification number:

RA-52867

• Issue
• Products affected
• What you should do
• Who is affected
• Report health or safety concerns
• Related AWRs
• Media enquiries
• Public enquiries
• What Health Canada is doing

Issue

Ranbaxy Pharmaceuticals Canada Inc., in consultation with Health Canada, is recalling one batch of RAN-Gabapentin, a medication used to treat epilepsy, due to cross-contamination during the manufacturing process with Etodolac, a non-steroidal anti-inflammatory drug.

The population at risk includes those who are hypersensitive to Etodolac, acetylsalicylic acid (ASA) or any other non-steroidal anti-inflammatory drug (NSAID). The risks include mild skin rashes, hives, and in rare instances, anaphylactoid reactions have also been reported during drug therapy with Etodolac.

For most adult patients, exposure to trace amounts of Etodolac will not represent a health risk and there are no contraindications for taking the two medications together.

Products affected

RAN-Gabapentin: Capsules 100 mg, Batch number 2582026, expiry date December 2015

What you should do

• Do not discontinue treatment with RAN-Gabapentin from the affected batch unless you have a history of anaphylaxis with NSAIDs.
• If you have a history of anaphylaxis with NSAIDs, speak to your pharmacist or doctor as soon as possible about obtaining unaffected medication or an alternative treatment.
• If you are on affected product and are having symptoms of allergic reaction, seek immediate attention.
• Contact your health care professional to obtain medical advice if you have taken any of the affected product and have concerns about your health.
• Report any adverse events to Health Canada.

Who is affected

Consumers using the affected batch of RAN-Gabapentin who are hypersensitive to Etodolac, acetyl-salicylic acid (ASA) or any other non-steroidal anti-inflammatory drug (NSAID).

Report health or safety concerns

• Call toll-free at 1-866-234-2345
• Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Related AWRs

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709

What Health Canada is doing

Health Canada is monitoring the recall by Ranbaxy Pharmaceuticals Canada Inc. The Department will continue to monitor the situation and update Canadians should new information be identified.