Second contraceptive recall in US for packaging errors
pharmafile | March 5, 2012 | News story | Manufacturing and Production |Â Â American Regent, Glenmark generics, McNeil ConsumerÂ
India’s Glenmark Generics has been forced to undertake a US-wide recall of seven lots of oral contraceptive product because of a packaging error that could raise the risk of unwanted pregnancy.
The norgestimate and ethinyl estradiol-based oral contraceptives are being recalled because the tablets in some packages may have been placed in the wrong order.
“The recall is being implemented because of a packaging error, where select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation,” said the company in a statement. The recall was prompted by a complaint from a member of the public.
“Consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately,” according to Glenmark, which notes that any blister for which the lot number and expiry date is not visible is subject to the recall.
This is the second recall of oral contraceptives because of packaging errors in as many 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.
Glenmark did not reveal how many packages are in each of the seven lots, or the total number of packages involved in its recall, but stressed that adequate supplies of the contraceptive remain on on the market.
Other recent recalls in brief
Drug distributor American Regent has recalled a single lot of its phenylephrine injection 1% product because of the presence of visible particles in the vials. The company says there have been no related side effects with the product, which is indicated for the maintenance of an adequate level of blood pressure during spinal and inhalation anaesthesia and for the treatment of some forms of vascular failure.
Johnson & Johnson’s troubled McNeil Consumer Healthcare unit has announced yet another recall, this time involving seven lots of grape-flavoured Infants’ Tylenol Oral Suspension, equivalent to 574.000 bottles. The recall was prompted by consumer complaints of faulty dosing syringes supplied with the product.
Phil Taylor
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