FDA investigations occurred during February to April of 2009 at a drug manufacturing plant.
A drug recall was instituted in July of 2009.
A voluntary nationwide recall of drugs is instituted on December 21, 2009.
In January of 2010, I am just hearing about it.
The drugs that were recalled were manufactured in a facility, which the FDA cited for violations, including:
- Failed to monitor and implement quality systems; noted to be a “repeat deficiency”.
- Drug products failed to meet standards, specifications and quality control criteria.
- Liquid drugs found to contain foreign particles.
- Tablets found with “unexplained spots”, but still released to market for sale.
- Drugs released to the market with unapproved specifications.
- Various flaws found in the internal investigation process and unqualified person(s) conducted the risk assessment investigation.
- Effective corrective and preventative actions were not taken by the manufacturer.
- Water used for manufacturing injection is also used for cleaning, vial washing, and is an ingredient in every product produced in the facility.
- Violations in incident reporting and investigation were found.
- In-process control procedures did not include examination of weight variations for tablets and capsules.
- FDA investigators were required to use flashlights in the “visual exam rooms” due to poor lighting. These are the rooms supposedly used for review of products.
- The FDA set forth that:
- “Determinations of conformance to appropriate written specifications for acceptance are not made for drug products.”
- “Specifically…there are lots of Epinephrine and lots of Xylazine 100 mg injection on the market which have not been tested for particulates. There are…other lots of intravenous products on the market that have never had particulate testing. The Vice President of Quality Management stated they have never conducted the particulate matter test for injectable products including Epinephrine and Xylazine.”
This is an investigation by the FDA, which culminated in a 20 page report of violations; a July 2009 consent decree; and a September 2009 recall.
The press release related to the consent decree set forth, among other things:
In the event of future violations, the consent decree also subjects Teva …Health to payments of $20,000 for each day the defendants fail to comply with any provision of the decree and an additional $25,000 for each shipment of…drugs in violation of the decree, up to $7.5 million per year.
Pretty scary, huh?
I told someone about this today and their response was, “well it is only involving animal drugs, so no big worries”.
I can read. I can research. I can speak up for my self. My animals can do none of these things. So, for all of you who are health advocates for your significant pets, the recalled drugs include:
- Ketaset (Fort Dodge/Pfizer)
- KetaVed (VEDCO), KetaThesia (Butler)
- VetaKet (LLOYD Laboratories)
- Ketaject (Phoenix)
- Keta-Sthetic (RVX)
- AmTech Group, Inc.
- EQUANOL (VEDCO)
- ButorJect (Phoenix)
- TorphaJect (Butler)
And for those of you who are not pet advocates, here is something to worry about. The manufacturer of all these “animal drugs”, Teva Pharmaceutical, also manufactures many drugs for humans as well.
So, no worries?