At Present, This March 2009 Recall Is Limited To Propafenone HCL 225 mg Tablets Shipped Between October 15, 2008 And November 26, 2008
(Posted by Tom Lamb at DrugInjuryWatch.com)
By means of a MedWatch Email Alert, on March 25, 2009 the FDA informed us about yet another quality control problem at a generic drug manufacturing facility.
From the March 25 MedWatch Alert:
FDA and Watson Pharmaceuticals notified healthcare professionals and patients of a recall of Propafenone HCL 225 mg tablets, a drug product used to treat cardiac arrhythmias. The drug is being recalled because some tablets may contain slightly higher levels of the active ingredient than specified. Because it has a narrow therapeutic index, some patients who are particularly sensitive to small variations in dose may experience potentially serious side effects, including arrhythmias (irregular heartbeat) or low blood pressure. The affected lot [lot number 112680A, expiration date July 31, 2010] of Propafenone HCL tablets was shipped to customers between October 15, 2008 and November 26, 2008.
The FDA also posted on its web site a press release about this Propafenone recall from the drug company, "Watson Announces a Nationwide Voluntary Recall of Propafenone HCL Tablets Due to Oversized Tablets", which added this additional information and guidance:
- [Recall involves just] one lot of Propafenone HCL 225 mg Tablets sold in 100 count bottles in the United States....
- No other strengths or lots were affected and the Company does not anticipate any product shortages as a result of this recall.
- Anyone who has 225 mg Propafenone HCL tablets should check the bottle for the lot number and expiration date to see if they have tablets being recalled.
- Patients using 225 mg Propafenone HCL tablets who have medical questions should contact their health-care provider.
This recall is apparently due to the fact that current Good Manufacturing Practices (cGMP) were not being followed at the facility where Watson makes its Propafenone HCL 225 mg Tablets.
As we have reported previously, here, during the past year there have been other cGMP violations leading to generic drug recalls by Actavis, ETHEX / KV Pharmaceutical, and Sandoz / Novartis.
The Digitek recall by Actavis-- which was manufacturing these generic digoxin pill for the Bertek and UDL divisions of Mylan Pharmaceuticals -- has given rise to hundreds of lawsuits filed by patients who used Digitek.
Some of those earlier generic drug recalls were initially limited to selected lots of one drug only to later be expanded to other generic drugs that were manufactured at the same plant. We will wait to see if additional lots of Propafenone HCL tablets, or any additional different drugs, are recalled by Watson in the coming weeks and months.