Advisory - Laboratoire Atlas Inc. is recalling one lot of "ATLAS - Codeine phosphate syrup 5 mg/mL" because some bottles contain isopropyl rubbing alcohol

OTTAWA, ON, Oct. 29, 2020 /CNW/ -

Summary

Product: ATLAS - Codeine phosphate syrup 5 mg/mL (DIN 00050024) lot number 35MC, expiry date 2023-03, Laboratoire Atlas Inc.
Issue: One lot of ATLAS - Codeine phosphate syrup 5 mg/mL is being recalled because some bottles contain isopropyl rubbing alcohol 70%.
What to do: Stop taking product from the affected lot and obtain a replacement product from your pharmacist. Consult with your doctor or pharmacist if you have any questions or concerns.

One lot of ATLAS - Codeine phosphate syrup 5 mg/mL, manufactured by Laboratoire Atlas Inc., is being recalled because some bottles contain isopropyl rubbing alcohol 70% and not codeine syrup. This is the result of a labelling error during the packaging process where Isopropyl rubbing alcohol products were mistakenly labelled as Codeine phosphate syrup 5 mg/mL.

All bottles from lot 35MC are being recalled as isopropyl rubbing alcohol is potentially toxic if ingested. Ingestion could lead to mild or serious adverse effects, such as sedation, stupor or coma, as well as gastrointestinal symptoms, such as discomfort. Isopropyl rubbing alcohol is intended to be used topically as an antiseptic skin cleanser or as a massage solution to relieve sprains, bruises and sore muscles.

Codeine phosphate syrup is a prescription drug used to treat mild to moderate pain. It can also be used for other medical conditions, including cough, in specific patient populations. Patients using product from lot 35MC would not receive the appropriate medication to control pain. A missed dose could trigger withdrawal symptoms since codeine products can cause physical dependence. These symptoms may include body aches, diarrhea, loss of appetite, nausea, nervousness or restlessness, runny nose, sneezing, tremors or shivering, stomach cramps, tachycardia or palpitations (rapid or unusual heart beat), trouble sleeping, an unusual increase in sweating, unexplained fever, weakness and yawning.

What Health Canada is doing
Health Canada is monitoring the effectiveness of the recall and any necessary corrective and preventative actions. Should new safety information arise, Canadians will be notified, as required.

What consumers should do

• Stop taking product from the affected lot and obtain a replacement product from your pharmacist.
• Check your bottles. Codeine phosphate syrup 5 mg/mL is a yellow syrupy solution. Isopropyl rubbing alcohol is a colourless liquid that smells like alcohol.
• Consult with your doctor or pharmacist if you have any questions or concerns regarding ATLAS - Codeine phosphate syrup 5 mg/mL.
• Report any health product-related adverse reactions or complaints to Health Canada.

Information for pharmacists:

• Check the bottles. Codeine phosphate syrup 5 mg/mL is a yellow syrupy solution. Isopropyl rubbing alcohol is a colourless liquid that smells like alcohol.
• Contact patients who have been dispensed a prescription from this lot of codeine phosphate syrup 5 mg/mL by your pharmacy.
• Report any complaint with this health product to Health Canada.

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SOURCE Health Canada

Media Inquiries: Health Canada, [phone], [email protected]; Public Inquiries: [phone], 1-866 225-0709