Regulatory Focus™ > News Articles > Sandoz Issues Recall After Packaging Errors Found

Sandoz Issues Recall After Packaging Errors Found

Posted 07 June 2012 | By Alexander Gaffney, RAC 

Novartis AG subsidiary Sandoz announced on Wednesday, 6 June the initiation of a recall for ten lots of its oral contraceptive Intravole (levonorgestrel) after consumers notified the company of a packaging mix-up.

Sandoz said the packaging error resulted in pills containing placebos being placed incorrectly within the blister packs, opening the possibility of consumers taking the oral contraceptives at the incorrect time. The blister packs ordinarily contain the placebo pills on the 13th and final row, but the packaging error resulted in the pills being placed on the 9th row instead.

"While the white placebo tablets can be clearly distinguished from the peach-colored active tablets, the risk of an unintended pregnancy for a patient taking the wrong tablet over several days cannot be excluded," explained Sandoz.

The company advised patients who find the incorrect sequence of tablets in their respective blister packaging to switch to a non-hormonal form of contraception and to contact their healthcare provider.

The recall occurs just three months after Warner Chilcott was warned by the US Food and Drug Administration (FDA) after the company was found to be manufacturing out-of-specification Ovcon oral contraceptive products.

Read more:

FDA - Introvale (levonorgestrel and ethinyl estradiol) Tablets: Recall - Packaging Flaw

Sandoz US Announces Precautionary Recall Of Oral Contraceptive Introvale®, Following Report Of Packaging Flaw


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