Third recall campaign for antihypertensive started
Third Recall for Hypertension - Shelf Life Incorrectly Specified
29/03/2011
The generic drug maker Dexcel has the third and final recall for the antihypertensive „amlodipine“ started. After 15 months, the tablets are no longer stable and consumers should therefore no longer use them, warned Dexcel.
All articles of the Hypotensioner „amlodipine“, on which the new shelf life of 15 months is not yet specified, are recalled by the generic manufacturer Dexcel. The date of expiry on the medicines was stated wrong and therefore to refrain from use, warned the pharmaceutical company. Of the recall are only possibly still in circulation old batches of the drug „amlodipine“ which had gone on sale until August 2010 with the old shelf life.
Antihypertensive was no longer stable after 15 months
Dexcel Pharma GmbH had found in routine quality studies that the antihypertensive „amlodipine“, other than stated on the packaging, after 15 months was no longer stable. Subsequently, a recall was decided on in several sections, on the one hand to remove the products from the market before the expiration date and, on the other hand, to ensure the continuous supply of the patients. The medicines were initially delivered in coordination with the competent authorities and should be withdrawn from the market after one year. Now the third and final round of this recall has started. The supply is still guaranteed, since since September 2010, the preparations have been supplied with an indication of the new shelf life.
Only one-thousandth of the blood pressure reducer will be returned
According to the pharmaceutical company, most of the antihypertensive products that still had their expiration date mislaid have already been taken off the market or used up. Thus, the return of the last recall in mid-December was below one tenth, and also in the context of the current recall was expected to be of a similar magnitude. „Amlodipine is a commonly needed drug; The batches are usually used up very quickly, so that hardly any old goods should be available at wholesalers and pharmacies“, the managing director of the pharmaceutical company Dr. Mathias Pietras, the low response rate. However, the Dexcel CEO does not know if all those concerned have actually noticed the recall and all non-returned items of the corresponding batch have already been consumed. Critical consumers are therefore faced with the question of why the mislabeled items were sold until September of last year or whether a security of supply could not have been ensured by other means. Here, for example, the immediate relabeling of the products would have been conceivable - but considerably more costly than the current solution. (Fp)
Picture: Andrea Damm