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Tridural (tramadol HCl extended release tablets) - Removal of Tablet Markings in Certain Lots
- Starting date:
- October 26, 2015
- Posting date:
- October 26, 2015
- Type of communication:
- Dear Healthcare Professional Letter
- Subcategory:
- Drugs
- Source of recall:
- Health Canada
- Issue:
- Important Safety Information
- Audience:
- Healthcare Professionals, General Public
- Identification number:
- RA-55566
Audience
Pharmacists and pharmacy staff.
Key messages
- The tablet markings (“LP 100”, “LP 200” and LP 300”) that help differentiate the 3 strengths of Tridural® tablets have been removed on certain lots.
- The lack of tablet markings may cause confusion to patients and increase the risk of medication errors.
- There are currently both marked and unmarked tablets on the market.
- Pharmacists can continue to dispense either marked or unmarked tablets, as there has been no change in formulation. Patients should be informed in order to avoid any potential confusion.
- Markings on Tridural® tablets will be reinstated on all future lots.
Issue
As of April 2014, Paladin Labs Inc. stopped printing tablet markings (“LP 100”, “LP200” and “LP 300”) on the associated strengths of Tridural® (tramadol HCl extended release tablets). There was no change to the formulation and there is no quality issue with the product. For a period of time, there may be marked and unmarked tablets on the market.
In order to avoid any potential confusion to the pharmacist or patient, the company will be reinstating markings on the tablets starting with the next manufactured lots.
Products affected
| Manufacturer | Product | DIN # | Product Code | Lot # | Expiry Date |
|---|---|---|---|---|---|
| Paladin Labs Inc. | Tridural® 100mg | 02296381 |
5000093 (UPC 6 2879100401 6) |
140878R2 | Sep 2016 |
| 141930R1 | Dec 2016 | ||||
| 145690R1 | Jun 2017 | ||||
| 145696R1 | Jul 2017 | ||||
| 145696R2 | Jul 2017 | ||||
| 145697R1 | Sep 2017 | ||||
| 148186R1 | Jan 2018 | ||||
| Tridural® 200mg | 02296403 |
5000094 (UPC 6 2879100402 3) |
143475R1 | Mar 2017 | |
| 143475R3 | Mar 2017 | ||||
| 145701R1 | Jun 2017 | ||||
| 148789R1 | Jan 2018 | ||||
| Tridural® 300mg | 02296411 |
5000095 (UPC 6 2879100403 0) |
143757R1 | Sep 2017 | |
| 146629R1 | Dec 2017 |
Background information
Tridural® is indicated for the management of moderate to moderately severe pain in adults who require treatment for several days or more. The product is available in white, plain, bevelled edge, round, biconvex, oral tablets. All three dosage strengths (100mg, 200mg and 300mg) are similar in appearance but differ in weight and size (see images below).
Who is affected
Information for consumers
Patients receiving Tridural® tablets should be informed that the tablets may be marked or unmarked. The tablets can be taken regardless of whether or not they are marked; their formulation is the same. Markings on the tablets will be reinstated on future lots. Patients should be reminded to keep the tablets in the original prescription container, to avoid any potential confusion or medication errors.
If you have any confusion as to what strength of unmarked tablet you are using, you should not take it and return it to the pharmacy for clarification.
Information for health care professionals
Please follow these instructions when dispensing unmarked Tridural® tablets:
- Inform patients that marked and unmarked tablets are available on the market and that they can continue to use the unmarked tablets as the formulation has not changed.
- Remind patients of the importance of keeping the product in the original prescription container to avoid any potential confusion or medication errors.
- Ensure to have a stock bottle available during dispensing to verify the dispensed product.
- Avoid dispensing both marked and unmarked tablets within the same prescription.
Action taken by Health Canada
Health Canada is communicating this important safety information to healthcare professionals via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication will be further distributed through the MedEffect™ e-Notice email notification system. Health Canada is working with the manufacturer to reinstate the markings on the Tridural® tablets.
Report health or safety concerns
Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of serious or unexpected side effects in patients receiving Tridural® should be reported to Paladin Labs Inc. or Health Canada.
Paladin Labs Inc.
100 Boulevard Alexis Nihon, suite 600
Montréal, QC H4M2P2
Telephone: 1-888-376-7830
To correct your mailing address or fax number, contact Paladin Labs Inc.
You can report any suspected adverse reactions associated with the use of health products to Health Canada by:
- Calling toll-free at 1-866-234-2345; or
- Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.
For other health product inquiries related to this communication, contact Health Canada at:
Health Products and Food Branch Inspectorate
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 1-613-946-5636
Original signed by
Jean De Serres, Vice President Scientific Affaires
Images
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