If you use a 25 mcg/hour fentanyl patch, you’ll want to check to see if it’s on this Actavis recall:

Actavis identified one lot of 25 mcg/hour Fentanyl patch (Control/Lot # 30349) shipped to market that contained one patch that released its active ingredient faster than the approved specification in laboratory testing. An accelerated release of Fentanyl from a 25 mcg/hour patch can lead to adverse events for at-risk patients, including excessive sedation, respiratory depression, hypoventilation (slow breathing), and apnea (temporary suspension of breathing). The patches are packaged individually and boxed in quantities of five patches per box.

Recalled Control/Lot #s

30041, Exp 12/2011
30258, Exp 03/2012

30049, Exp 12/2011
30349, Exp 03/2012

30066, Exp 12/2011
30350, Exp 03/2012

30096, Exp 01/2012
30391, Exp 03/2012

30097, Exp 02/2012
30392, Exp 04/2012

30123, Exp 01/2012
30429, Exp 04/2012

30241, Exp 02/2012
30430, Exp 04/2012

30256, Exp 02/2012
30431, Exp 04/2012

30257, Exp 03/2012
30517, Exp 04/2012

Source: Recalls, Market Withdrawals, & Safety Alerts > Actavis Inc. Issues a Voluntary Recall of 18 Lots of Fentanyl Transdermal System 25 mcg/h

I would also suspect that a defective fentanyl patch like this could lead to death from acute fentanyl intoxication.  If you have a recalled patch, definitely click the link above to the FDA and follow the directions on exchanging the patches.

People keep finding my blogs by searching for things like "Can you eat a fentanyl patch?" 

NO!

Eating a fentanyl patch has a VERY good chance of killing you.  The patches are designed to deliver fentanyl at a constant amount over a period of three days.  Eating it will give you the full dose all at once. 

I have personally seen autopsy reports and death certificates from people who have eaten fentanyl patches.  One poor guy was only 18 years old and experimenting with friends.  He died within hours of eating the patch.

Please, if you're considering eating a fentanyl patch, or considering injecting the fentanyl gel – DON'T.

I just generically refer to “Mylan” when I mean any one of several Mylan companies.  The best information I’ve seen so far about which Mylan is which comes from their own in-house litigation counsel, Brian Cutherbertson.  He filed a three page affidavit on August 13th of 2009 in the case of Boles v. Mylan.  In it, he details the corporate makeup of Mylan:

5. There is no entity presently operating under the name Mylan Laboratories, Inc. In October, 2007, Mylan Laboratories Inc. officially changed its name to Mylan Inc. ("Mr').

6. MI is a holding company incorporated under the laws of the Commonwealth of Pennsylvania, with its principal place of business at 1500 Corporate Drive, Canonsburg, PA 15317.

7. MI is a shareholder of companies involved in the production of quality generic and specialty pharmaceutical products.

8. MTI is a wholly owned subsidiary of MI and is a corporation organized and existing under the laws of the State of West Virginia with its principal place of business in St. Albans, Vermont.

9. On January 28,2005,M TI received approval from the federal Food and Drug Administration (" FDA") for the manufacture of the Mylan Fentanyl Transdermal System ("MFTS''). A true and correct copy of the FDA approval letter issued on January 28,2005, is attached to this Affidavit as Exhibit No. 1.

10. Pursuant to an Abbreviated New Drug Application submitted by MTI, FDA issued approval for MTI's manufacture of the MFTS concluding that the product was safe and effective when used in accordance with its approved labeling.

11. Since obtaining FDA approval on January 28, 2005, MTI has manufactured the MFTS at its production facilities in St. Albans, Vermont. Distribution of the MFTS is handled through MPI, another wholly owned subsidiary of MI. MPI is a West Virginia corporation with its principal place of business in Morgantown, West Virginia.

12. I understand that the Original Petition filed on behalf of plaintiff in this matter claims that Ms. Vail died on July 12, 2006, allegedly as a result of complications stemming from her use of the MFTS.

13. The MFTS was, at all times, developed, formulated, and manufactured by MTI. Since FDA approval of the product, MPI has been the entity responsible for the distribution and sale of the MFTS.

14. The Original Petition alleges, at paragraph 2.8, that MI, MTI, MPI, Mylan Bertek Pharmaceuticals, Inc. ("MBP"), and VDL Laboratories, Inc., are collectively " engaged in [the] business of designing, manufacturing, marketing, distributing, selling, and otherwise placing into the stream of commerce the [MFTS]." This allegation is incorrect.

15. MBP is a registered Texas corporation that is a wholly owned subsidiary of MI. However, MBP ceased all operations in June of 2005.

16. Thus, while MBP exists as a registered Texas corporation, it has no offices, employees, manufacturing facilities, warehouse, or sales staff in Texas or elsewhere. Moreover, MBP was never involved in any aspect of the design, manufacture, marketing, distribution, or sale of the MFTS.

17. Because the operations of MBP ceased in 2005, this entity absolutely was not involved in the development, manufacture, distribution, or sale of the pharmaceutical product allegedly used by Plaintiff's Decedent in 2006.

18. The final entity named in the Original Petition is VDL Laboratories, Inc. VDL Laboratories Inc. is an Illinois corporation with its principal place of business in the State of Illinois. Like MTI, UDL Laboratories, Inc. had no role or involvement in any aspect of the design, manufacture, marketing, distribution, sale, or supply of the MFTS.

If there are any typos in the above, blame my OCR software, not Mr. Cuthbertson.

Hopefully this document will help plaintiffs’ attorneys figure out which corporate entity to sue in a fentanyl lawsuit.

Watson makes a generic version of the Duragesic fentanyl patch using the reservoir design.  Like Alza, the company that makes Duragesic, Watson has had recalls due to defective patches.

Watson Recalibrates Equipment After Fentanyl Patch Recall

Watson Pharmaceuticals has adjusted calibration for a machine that manufactures its fentanyl transdermal patches after a small number of them that leaked prompted a voluntary recall of one lot of the product.

Source: Watson Recalibrates Equipment After Fentanyl Patch Recall

At my new blog, www.findtherightduragesicfentanylpatchlawyer.com, I’ve posted a variety of documents from Duragesic lawsuits.  These lawsuits pertain only to the brand name Duragesic patch, or the Sandoz/Actavis generic patch, as it is made in the same factory.

If you have any documents from Duragesic lawsuits, I’d love to post them here or at my other blog.  Or, if you’re looking for a Duragesic lawyer, contact me and I’ll put you in touch with a lawyer who I feel can help you.  I don’t ever get paid for introducing you to my friends, but instead make these introductions because I want to help people hold the fentanyl patch manufacturers accountable for selling a dangerous pain patch.

These documents pertain only to generic fentanyl patch lawsuits, not against the makers of the brand-name Duragesic patch.

On the very first day of the fictional Fentanyl 101 class, you would learn that Duragesic is the original fentanyl patch, and that anything else is a generic.

I’ve launched a new web site that will provide information about fentanyl lawyers & lawsuits, fentanyl side effects, and other noteworthy information about generic fentanyl patches.  My new website won’t have much information about Duragesic fentanyl patches, other than coverage of lawsuits between the manufacturer of Duragesic and its competitors.

If you’ve got any news about fentanyl pain patches, generic or otherwise, let me know and I’ll post it.  If you’d like me to introduce you to a fentanyl lawyer, you should also let me know.

A reader brought to my attention that all of Mylan's fentanyl patches are made in Vermont, not West Virginia.  Therefore, no matter if the allegations that West Virginia employees bypassed safety mechanisms are true, that could in no way have any bearing on the safety of the Mylan fentanyl patch.

Hopefully, no similar conduct occurred on the fentanyl line in Vermont.

What's next in the saga of Mylan, the fentanyl patch manufacturer whose employees allegedly bypassed quality controls? 

NEW YORK, July 29 (Reuters) – Mylan (MYL.O), the world's No. 3 generic drugmaker, said on Wednesday that it had reshuffled its management after a report on its quality controls sparked volatility in its share price.

Heather Bresch, formerly chief operating officer, is being promoted to the position of president, and Rajiv Malik will take on the role of chief operating officer, the company said. Most recently, Malik headed global technical operations, overseeing quality and regulatory affairs, among other areas.

Source: Reuters

Not sure what to make of the fact that the individual who was chagred with "overseeing quality and regulatory affairs" got a promotion out of this… but then again, the allegations are that employees hid defects from the quality control department.

Yesterday, I blogged about the allegations that Mylan employees knowingly bypassed safety procedures to boost production.  Today, there's another story worth blogging about:

According to a press release issued by Mylan, the plant has been cleared of any problems by the Food & Drug Administration following a visit to the facility by agency officials on Monday. But in its statement the FDA’s assistant commissioner for compliance policy, Steven Solomon, said the investigation is not over.

“This investigation involves allegations of compliance violations that the FDA takes very seriously,” Solomon wrote. “The investigation is ongoing and the agency has formed no conclusions at this time. Statements to the contrary are untrue.”

Source: FDA, Mylan, at odds over status of probe at W.Va plant

I'm sure Mylan would like the investigation to be over, but I for one am relieved that the FDA is continuing to look into these allegations.  Many of the products made at this West Virginia plant, like Mylan's fentanyl patch, can be deadly if not manufactured according to specifications.

Considering how many lawsuits have already been filed against Mylan alleging their fentanyl patch is defective, I can't help but wonder if the safety procedures were skipped on the fentanyl line…