Recall of One Lot of Rexall Extra Strength Sinus Relief Daytime and Nighttime Caplets

Starting date:

March 12, 2012

Posting date:

March 12, 2012

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Product Safety, Labelling and Packaging

Audience:

General Public

Identification number:

RA-110005514

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Health Canada is informing Canadians that Vita Health Products is conducting a voluntary recall of lot 00058398B of the "combo pack" Rexall Extra Strength Sinus Relief Daytime and Nightime Caplets due to a labelling error that misidentifies the daytime and nighttime medications (see photos below). The lot number is printed on the blister pack just above the expiry date.

Consumers are cautioned that the text printed on the back of the blister foil incorrectly identifies the nighttime caplets as the daytime caplets and the daytime caplets as nighttime caplets. Compared with the daytime caplets, the nighttime caplets also contain enough diphenhydramine hydrochloride to be used as a sleep aid. Taking a nighttime caplet during the day may result in drowsiness and have safety consequences when engaging in activities requiring alertness, such as driving.

The daytime medication is intended for nasal and sinus congestion, sinus pain and headache, while the nighttime medication is intended for the nighttime relief of these symptoms, as well as itchy and watery eyes, and allergy relief.

Health Canada is not aware of any reports of injury or adverse reaction due to this labelling error. However, consumers mistaking the nighttime caplets for daytime caplets may be more prone to serious accidents due to the sedation or sleepiness associated with the use of diphenhydramine.

The product was available in retail stores across Canada. The company is advising wholesalers, pharmacies and other retail locations to return unused tablets from the affected lot to their distributor or Vita Health for destruction. 

For more information concerning the recall consumers should contact Vita Health Products directly at 1-800-665-8820.

Health Canada is monitoring the recall by Vita Health Products and will continue to provide updates to Canadians if new safety information is identified.

To report suspected adverse reaction to these or other health products, please contact the Canada Vigilance Program of Health Canada toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:

• Fax: 1-866-678-6789
• Internet: www.healthcanada.gc.ca/medeffect
• Mail: Canada Vigilance Program
  
  Marketed Health Products Directorate
  
  Ottawa, ON, Address Locator 0701E
  
  K1A 0K9

Media enquiries

Health Canada

613-957-2983

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613-957-2991

1-866-225-0709

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