Fresenius Kabi Recall Issued For Generic Cogentin Injections

Glass particles have contaminated four lots of generic Cogentin sold by Fresenius Kabi, leading to a recall of the drug that is used to treat muscle and movement disorders.

The Benzotropine Mesylate injection recall was announced by the FDA on June 30, after visible particles were seen in vials.

While there have been no adverse events reported in connection with the recalled Cogentin generic equivalent, glass particulate matter in a parenteral drug may pose a serious safety risk for patients.

According to Fresenius Kabi USA, a subsidiary of Fresenius SE & Co., the particulate contamination is due to glass delamination, and while the problem was discovered because visible particles were seen, the particles could be hard to see or nearly invisible for consumers or medical providers.

The company warns that injection of the glass particles could cause problems ranging from mild inflammation and allergic responses to more severe injury or death, including pulmonary embolism, blockage of capillaries or arterioles, and other problems.

Benzotropine Mesylate is the generic version of Cogentin, It is used to treat all forms of Parkinsonism, including dystonia and Parkinson’s disease.

The recall affects four lots of Benzotropine Mesylate Injection, USP 2 mg/2 mL (1mg/mL) in 2 mL single dose vials sold under the Nexus Pharmaceuticals or APP labels. The recalled vials sold under the Nexus label have an NDC Number of 14789-300-02, and a product code of 1478930002. Three lots from Nexus are affected; lot 030712 with an expiration date of 03/2014 was shipped between 05/18/2012 and 09/24/2012, lot 071212 with an expiration date of 07/2014 was shipped between 09/21/2012 and 10/15/2012, and lot 090512 with an expiration date of 09/2014 was shipped between 10/10/2012 and 11/20/2012. The fourth lot was sold under the APP label with an NDC Number of 63323-970-02, a product code of 970102, and lot number 111412. Those vials have an expiration date of 11/2014 and were shipped between 02/06/2013 and 05/31/2013.

Production of the drug has been discontinued until the cause of the contamination can be determined. The company has not given any indication of how long the discontinuation will last or how availability of the drug will be affected.

Health care professionals with questions should call Fresenius Kabi USA Quality Assurance at (866) 716-2459. They can also visit the website at http://www.apppharma.com/our-products/product-updates. Customers concerned with availability and ordering can call Fresenius Kabi USA Customer Service at (888) 386-1300.

Fresenius Dialysis Recall Lawsuits

Fresenius Kabi is one of four companies that make up Fresenius SE & Co. KGaA. One of its sister units, Fresenius Medical Care, is currently under fire for how it handled a recall of Granuflo and NaturaLyte, two dialysis products that were commonly used at Fresenius dialysis clinics and other centers owned by other companies.

Several hundred Fresenius dialysis treatment lawsuits have been filed in courts throughout the United States on behalf of individuals who suffered sudden heart problems or death that occurred during or shortly after treatment. The complaints allege that Fresenius withheld important information from doctors at their own clinics and from the entire medical community about the risks associated with Granuflo and NaturaLyte, including the importance of monitoring bicarbonate levels for patients treated with the products.

Fresenius issued an internal memo to their own clinics in November 2011, indicating that an internal review of patients treated at 667 Fresenius dialysis clinics in 2010 and found at least 941 instances where individuals suffered cardiac arrest during dialysis treatment. The memo warned physicians at Fresenius clinics about the importance of monitoring bicarbonate levels, but the company failed to provide this information to other clinics that used Granuflo and NaturaLyte.

After the internal memo was leaked to the FDA in March 2012, Fresenius finally provided a warning letter to all healthcare providers, which the FDA has classified as a NaturaLyte and Granuflo recall.