Labeling mishaps on oral drugs have surfaced much too often lately. In February, two birth control manufacturers announced recalls of their oral contraceptives due to labeling errors on product packaging. The mistake put thousands of women at risk to unintended pregnancy. Now, a Canadian drug manufacturer, Rexall, announced a packaging error on its over-the-counter extra strength sinus relief daytime and nighttime caplets. The daytime and nighttime tablets, together in one “combo pack” are mislabeled. 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.
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. While there is no information that indicates these products were sold directly in the United States, Rexal products generally are available in the U.S., although sales are mainly limited to herbal supplements.
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.