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Health trends

Published:Wednesday | June 13, 2012 | 12:00 AM

Contraceptive pills recalled

Sandoz notified the public that it issued a voluntary recall of 10 lots of its generic oral contraceptive Introvale (levonorgestrel and ethinyl estradiol) in the US, following a recent report of a packaging flaw.

A consumer reported that the white placebo tablets were mistakenly in the ninth row (labelled 'Week 9') of the 13-row blister card, rather than in the correct position in the 13th and final row (labelled "Week 13"). Each three-month blister card contains 84 peach-coloured active tablets and seven white placebo tablets in 13 rows, each representing one week. While the white placebo tablets can be clearly distinguished from the peach-coloured active tablets, the risk of an unintended pregnancy for a patient taking the wrong tablet over several days cannot be excluded.

The lot numbers involved in the recall are as follows: LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C and LF01261C. These lots were distributed only in the US between January 2011 and May 2012.

BACKGROUND: Introvale is an extended-cycle oral contraceptive. Sandoz is not aware of any reports of related adverse events.

RECOMMENDATION: If a patient finds a white placebo tablet in any position other than the 13th and final row (Week 13), they should immediately begin using a non-hormonal form of contraception and contact their health-care professional.

Source: US Food and Drug Administration

Dietary supplement recalled

Botanical Laboratories Inc. and US Food and Drug Administration notified consumers and health-care professionals of a recall of Wellesse Digestive 3 in 1 Health liquid dietary supplement. A supplier of one of the ingredients indicated the ingredient has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Healthy persons infected with Salmonella often experience: fever, diarrhoea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

BACKGROUND: Product lots affected by this recall include: 16 oz size with "LOT 34441C (followed by a four-digit time code) A EXP 03/2014" jet coded on the bottom of the bottle. 33.8oz size has "LOT 34552C (followed by a four-digit time code) A EXP 03/2014" jet coded on the bottom of the bottle.

Both 33.8oz and 16oz "Digestive 3 in 1 Health" were distributed nationwide in the US through retail stores, and online retailers. The product was distributed after May 1, 2012.

Source: US Food and Drug Administration