Pfizer recalls oral contraceptive for packaging errors
pharmafile | February 2, 2012 | News story | Manufacturing and Production | Akrimax, Bedford, Cephalon, Lo/Ovral-28, Pfizer, Teva
Pfizer has been forced to recall a large volume of oral contraceptive packs distributed in the US market because a packaging error could leave women at risk of an unwanted pregnancy.
The company has recalled 14 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol), as well as 14 lots of a generic equivalent, because some blisters may contain “an inexact count of inert or active ingredient tablets”, according to a statement. Some of the tablets may also be out of sequence, said the firm.
The affected products were manufactured and packaged by Pfizer for commercialisation by privately-held firm Akrimax Pharmaceuticals.
Lo/Ovral and the generic are supplied in blister packs containing 21 white tablets with oestrogen and progestin ingredients, and seven pink inert pills that contain no hormones. Each pack contains six blister strips, and it is estimated that around a million packs may be affected by the recall.
Pfizer said that women exposed to the defective packs are not facing any immediate health risks, but it recommends that should begin “using a non-hormonal form of contraception immediately”.
Other recent recalls in brief
Teva subsidiary Cephalon has initiated a US-wide recall of Treanda (bendamustine HCl), an injectable drug used to treat chronic lymphocytic leukaemia, after discovering glass fragments in a single vial of the product. One lot of the drug – in 8ml vials – is being recalled, according to the FDA. The lot was reportedly manufactured by another Teva subsidiary based in the Netherlands called Pharmachemie BV.
Boehringer Ingelheim unit Bedford Laboratories has recalled several lots of Polymyxin B for injection in 500,00-unit vials, and vecuronium bromide for injection in 10mg and 20mg vials after discovering glass particles. Polymyxin B is used in the treatment of acute infections caused by Pseudomonas aeruginosa, while vecuronium bromide is indicated as an adjunct to general anaesthesia.
Phil Taylor
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