Health product recall

PMS-Hydromorphone: Affected lot may contain tablets that could potentially lead to overdose

Last updated

Summary

Product
PMS-HYDROMORPHONE TAB 2 MG
Issue
Health products - Adverse reaction
Health products - Dosage
Health products - Labelling
Health products - Packaging
Health products - Product safety
Health products - Product withdrawal
What to do

Check your bottle of pms-Hydromorphone to ensure you have the correct tablets. Stop using product from the affected lot and contact your pharmacy immediately for a replacement product.

Affected products

Brand Product Name Market Authorization Dosage Form Strength Lot
PMS-HYDROMORPHONE TAB 2 MG PMS-HYDROMORPHONE TAB 2 MG DIN 00885436 Tablet HYDROMORPHONE HYDROCHLORIDE 2 MG 639268

Issue

Pharmascience Inc. is recalling one lot of pms-Hydromorphone, 2 mg tablets, (lot 639268) as the bottles may contain hydromorphone tablets of a different strength (8 mg), meaning they contain higher amounts of hydromorphone. Products from the affected lot were sold between May 2022 and August 2022.

The 2 mg hydromorphone tablets are round and orange with a "2" on one side of the tablet and "pms" on the other side. The 8 mg hydromorphone tablets are round and white with an "8" on one side of the tablet and "pms" on the other side.

Hydromorphone is an opioid medication used to treat pain and opioid use disorder.

Accidentally taking too much hydromorphone (one dose of 8 mg of hydromorphone instead of one dose of 2 mg) or suddenly increasing the dose of hydromorphone could potentially lead to an overdose, which can be life-threatening even in people who have some tolerance to opioids.

Symptoms of hydromorphone overdose may include: dizziness, drowsiness, confusion, slow heartbeat, slow and difficult breathing, cold and clammy skin, seizure, coma and death.

Patients and their caregivers should be aware of the signs and symptoms of hydromorphone overdose, and should seek medical attention immediately if any of these symptoms are noted. If naloxone is available, be prepared to administer it.

The Department is monitoring the company's recall and will inform the public if any new health risks are identified.

What you should do

  • Check your bottle of pms-Hydromorphone to ensure you have the correct tablets. The 2 mg hydromorphone tablets are round and orange with a "2" on one side of the tablet and "pms" on the other side. The 8 mg hydromorphone tablets are round and white with an "8" on one side of the tablet and "pms" on the other side.
  • Stop using product from the affected lot and contact your pharmacy immediately for a replacement product.
  • If you have accidentally taken the 8 mg hydromorphone tablet instead of the 2 mg hydromorphone tablet and you have any health concerns, or are unsure whether you have taken too much hydromorphone, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. If naloxone is available, be prepared to administer it.
  • If you have any questions about the recall, contact Pharmascience Inc. at medinfo@pharmascience.com or 1-888-550-6060.
  • Report any health product adverse events or complaints to Health Canada.

Additional information

Previous recalls or alerts
Background

Depth of recall: Wholesale, Retailers

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies

If you have any questions about the recall, contact Pharmascience Inc. at medinfo@pharmascience.com or 1-888-550-6060.

Published by
Health Canada
Audience
General public
Healthcare
Health professionals
Hospitals
Industry
Retail
Recall class
Type I
Identification number
RA-64487

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