[NOTE: This blog has been updated as recently as December 14, 2015. Please see the 'UPDATE 12/14/15' section below for more information.]
UPDATE - 12/14/15:
There has been new information regarding the March 2015 recall of Deflazacort batches JL21 and JL28. It seems that these batches were recalled due to a suspected lack of stability of the drug when stressed by time, temp, etc. Batches of drugs imported into the US are randomly “stress tested” to make sure that, if they are stopped in port for a period of time (“stressed”), that they will retain their stability. Those 2 batches of deflazacort were suspected of instability, so they were recalled.
Masters Marketing reports that, although they did have a brief issue with supply, that they are now fully stocked.
Masters now does require an annual letter of importation from prescribing providers (NHRA requirement), which they are trying to simplify as much as possible. However, as a result, all imported drugs are now packaged to include the letter, invoice and prescription, so if the drug is stopped in customs, it should be much easier to get it released. Masters has also switched to DHL as their currier – packages will now arrive in 2-4 business days and can be tracked.
ORIGINAL ARTICLE - 3/12/15:
PPMD has been in touch with Masters Pharmaceuticals regarding a recall that was sent to many families regarding a recent shipment of Deflazacort. Here is what they told us:
The recall is specific to Deflazacort 30mg, (Marketing Authorisation Holder: Sandoz) and was recently issued by the Spanish Agency of Medicine. The batches that are affected and subject to the recall notification are J021 (expiry 30/06/2017) and J028 (expiry 30/09/2017). Masters is currently trying to establish the reason for the recall but have no further information at this time, but they are working with the Products manufacturer. They are contacting ~230 customers who purchased the affected batches however, we believe that most will only have batch J028 remaining.
If you receive this recall notice and/or think that you may have an affected batch, you should contact your neuromuscular provider and ask them to replace it with a prescription for prednisone to take until you get your new batches of deflazacort. Do not take deflazacort that is part of the affected batch.
If your doctor prescribes prednisone the conversion rate is as follows:
6mg deflazacort = 5mg prednisone
30mg deflazacort = 25mg prednisone
As more information becomes available, we will share it with the community immediately. If you have any further questions call your neuromuscular provider.
UPDATE 3/12/15 - 4 PM:
We are in contact with Masters. At the moment there is no definition for 'defective' which could range from a packaging issue to an issue with the compound itself. To date, there are any number of families whose children have been taking pills from these batches for a period of weeks to months. We are not aware of any report from families about acute illness or unknown side effects. The best thing to do is to return the batches in question and to switch to prednisone if you have no other deflazacort available. Masters is working hard to clarify this situation and we should learn more very soon.
UPDATE 3/12/15 - 5PM:
We have heard from Masters Marketing. The batch recall is classified as Class 2, the definition of which is below. Class 1 is more serious and warrants greater concern. Class 2: Defects, which could cause illness or mistreatment but are not Class 1.
Examples: 2.1: Mislabelling: e.g. wrong or missing text or figures. 2.2: Missing or incorrect information - leaflets or inserts. 2.3: Microbial contamination of non-injectable, non-ophthalmic sterile product with medical consequences. 2.4: Chemical/physical contamination (significant impurities, cross-contamination, particulates). 2.5: Mix up of products in containers (“rogues”). 2.6: Non-compliance with specification (e.g. assay, stability, fill/weight). 2.7: Insecure closure with serious medical consequences (e.g. cytotoxics, child-resistant containers, potent products).