A recall of a medication is an action taken either by FDA (Food and Drug Administration) request, FDA order or the manufacturing companies own initiative. Any situation where there is reasonable probability that the use of the product will cause serious adverse consequences or death, temporary adverse consequences that can be medically reversed, or even when use is not likely to cause adverse consequences but there is a violation in manufacturing, warrants a recall. The following medications prescribed to treat high blood pressure have been recalled.
Class II Recall
The following medications were recalled under the FDA Class II recall standards. Class II recalls are initiated when the product either has a probability to cause temporary or medically reversible adverse consequences or has a remote possibility to cause adverse consequences.
Metoprolol Succinate
Metoprolol succinate, also sold as brand name Toprol XL, is prescribed to treat a variety of heart problems including high blood pressure, heart attack and abnormal heart rhythms. In November 2008 lots of the following medications with expiration dates before August 2010 were voluntarily recalled by the manufacturer Ethex Corporation. This recall includes medications manufactured by Sandox Inc. as well. The recall was initiated by the manufacturer due to a lack of documentation and in-process controls that may cause the medication to be out of specification before their expiration date.
Metoprolol 25mg
Metoprolol succinate extended release 25mg tablets are recalled. The following lots are specifically mentioned: 58177-293-04, 58177-293-09 and 58177-293-11.
Metoprolol 50mg
Metoprolol succinate extended release 50mg tablets are included in the recall. Retailers are instructed to watch for lots 58177-369-04, 58177-369-09 and 58177-369-11.
Metoprolol 100mg
Metoprolol succinate extended release 100mg tablets are recalled. Lots 58177-368-04, 58177-368-09 and 58177-368-11 are specifically mentioned in the recall letter issued by Ethex Corporation.
Metoprolol 200mg
Metoprolol succinate extended release 200mg tablets with lot numbers 58177-358-04, 58177-358-09 and 58177-358-11 are also included in the recall.
