Packaging errors spark fourth oral contraceptive recall

pharmafile | June 12, 2012 | News story | Manufacturing and Production Introvale, Novartis, Sandoz, manufacturing, recall 

There has been yet another case of an oral contraceptive being recalled because packaging errors could lead to unwanted pregnancy, with the latest incident involving Novartis’ generics subsidiary Sandoz.

The firm has been forced to recall 10 lots of its generic Introvale birth control pills distributed in the US only between January 2011 and May 2012, after reports of a packaging flaw.

The consumer noticed that the white placebo tablets were incorrectly placed in the ninth row of the 13-row blister card – corresponding to week nine of the course – rather than in the correct position in the 13th and final row.

“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,” said Sandoz in a statement.

The company has recommended that women who discover they have a mis-packaged product use non-hormonal contraception and seek medical advice.

This is the fourth recall of oral contraceptives because of packaging errors in the last few months in the US.

In early February, Pfizer recalled 28 lots of its Lo/Ovral product plus a generic equivalent because of out-of-sequence tablets. In the same month, generic firm Glenmark recalled seven lots of its norgestimate and ethinyl estradiol-based oral contraceptives, once again because the tablets in some packages were placed in the wrong order.

Meanwhile, in September 2011 Endo Pharmaceuticals’ subsidiary Qualitest pulled back seven lots of oral contraceptives because in some cases blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and rendering the lot number and expiration date invisible.

Other US drug recalls in brief

Hospira announced a nationwide recall of one lot of its injectable Carpuject (hydromorphone) opioid analgesic after two complaints of overfilling of the glass cartridge used in the formation. The company has also recalled one lot of a morphine sulfate injection for the same reason. Opioid pain medications such as hydromorphone can have life-threatening consequences if overdosed, noted the company in a statement.

American Regent has recalled a single lot of an epinephrine product because of discoloration and small visible particles found in some of the 1mL ampoules. It is possible that the lot was exposed to light, which can cause colour changes and the formation of precipitates.

Phil Taylor

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