Many Patients Are Dissatisfied With Lack Of Information From Sandoz, FDA, Or Their Pharmacy About Why This Generic Toprol Pill Was Pulled
(Posted by Tom Lamb at DrugInjuryWatch.com)
In an August 26, 2008 Drug Injury Watch post, "FDA Warns Sandoz About Possible Quality-Control Problems At Its North Carolina Generic Drug Manufacturing Facility", I reported FDA inspectors found that Sandoz had failed to properly validate its manufacturing process for Metoprolol Succinate ER Tablets (Generic Form Of Toprol XL).
Here is the August 12, 2008 FDA Warning Letter (08-ATL-13) sent to Sandoz concerning the"Good Manufacturing Practices" (GMP) problems found at its generic drugs facility located in Wilson, North Carolina.
Returning to my earlier post, there I noted:
It is unclear as of August 26 whether Sandoz will cease distribution of its metoprolol succinate ER tablets (generic Toprol XL) and/or issue a recall of this medication. We will be watching for these possible related developments.
Well, in the few months that followed we never saw any Metoprolol Succinate ER Tablets recall notice from the FDA nor Sandoz.
Starting in November 2008, however, we started to get some Comments submitted to the August 26 post which indicated that, in fact, some type of recall was underway. And elsewhere on the web, such as this Topix forum, "recall at Rite-aid -- Posted in the Metoprolol (generic), Toprol XL Forum", there were various reports coming in to this effect.
Thankfully, one of the participants in that Topix forum posted a link to this November 12, 2008 notice, "Recall: Metoprolol ER Tablets by Sandoz" published online by Pharmacy Industry News:
Sandoz is voluntarily extending the September 17, 2008, recall of Metoprolol Succinate Extended Release Tablets 25mg and 50mg, to include all strengths of distributed lots with expiration dates through August 2010. This voluntary action by Sandoz is due to deficiencies in documentation practices and in-process controls for this product. This voluntary recall is being conducted down to the retail level with the knowledge of the FDA. The affected lots were shipped approximately between November 2006 and October 2008. (Sandoz Press Release 11/3/08)
Unfortunately (but not surprisingly) I could not find the above-referenced November 3, 2008 press release on the Sandoz web site when I checked today, nor could I find there any press release about this Metoprolol Succinate ER Tablets recall from back in September 2008.
Likewise, there is nothing to be found readily on the FDA's web site about this Sandoz Metoprolol Succinate ER Tablets recall.
If you have more information about how Sandoz is carrying out this relatively "quiet" recall of its Metoprolol Succinate ER Tablets, please let us know by submitting a Comment, below, or sending me a private email.
P.S. AstraZeneca issued a May 18, 2009 press release to announce that all wholesale ordering restrictions in place for its Toprol-XL (metoprolol succinate) extended release tablets have been removed and that supply levels of Toprol-XL are approaching near usual levels at all points in the distribution chain. (5/21/09)