Heritage Pharmaceuticals Doing The Right Thing--

 

Heritage Pharmaceuticals has initiated a nationwide voluntary

recall of ten lots of colistimethate for injection (150 mg) and

three lots of rifampin for injection (600 mg) because of

concerns over lack of  sterility.

 

Colistimethate is indicated for the treatment of acute or

chronic infections due to sensitive strains of certain gram-

negative bacteria.

 

 Rifampin is indicated for the treatment of all forms of 

tuberculosis.The recalled colistimethate has national drug code

(NDC) 23155-193-31, and the recalled rifampin has NDC

23155-340-31.

Both products are sold in single-vial monocartons in case packs

of ten. The recall (to the user level) stems from observations by

the US Food and Drug Administration (FDA) regarding aseptic

and general manufacturing practices at the manufacturer's site

potentially affecting product sterility, according to a company

news release posted on the FDA website. "Intravenous

administration of nonsterile injection products to a normally

sterile site may result in a site-specific or systemic infection,

which in turn may cause hospitalization, significant morbidity

(permanent organ damage), or fatal outcome. To date, Heritage

 is not aware of any adverse patient events resulting from the

use of the subject product lots," the release says.

 

The recalled products were distributed to hospitals, wholesalers, and distributors nationwide from December 2012 through January 2015 for colistimethate and from October 2014 through January 2015 for rifampin.

Customers are being notified by fax, email, United Parcel Service, and/or certified mail to return all recalled product.

Heritage asks all customers to check their inventory "immediately and to quarantine, discontinue distribution of, and return the recalled lots of product. Customers who may have further distributed these products have been requested to identify their customers and notify them at once of this product recall."

Questions regarding this recall can be directed to the customer call center at (866) 901-1230 Monday through Friday from 9:00 am to 5:00 pm Eastern Standard Time.

Adverse reactions or quality problems experienced with the use of these products should be reported to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch- online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

 

 

 

 

	

Unsafe and Contaminated Medications Released To American's

The Brooklyn (NY) Daily Eagle reported that “the federal

government” has “unsealed a 37-count indictment

charging Med Prep Consulting Inc. with wire fraud and

violations of the Federal Food, Drug and Cosmetic Act

(FDCA).” The company, “together with its owner and

president, Gerald Tighe, and pharmacist-in-charge,

Stephen Kalinoski, allegedly introduced adulterated and

misbranded drugs into the commerce stream and

misbranded drugs with the intent to defraud and mislead

the US Food and Drug Administration (FDA) and Med

Prep’s customers, who consisted of hospitals and other

healthcare providers.” The Daily Eagle added,

“According to the indictment, Med Prep processed

numerous drugs...in purportedly sterile conditions. In an

effort to gain market share, Med Prep repeatedly

misrepresented to its healthcare provider customers that

 it adhered to, and in some areas exceeded, industry

standards and laws applicable to sterile drug

preparation.” FDA Commissioner Hamburg said, “The

production of unsafe and contaminated drug products

poses a serious threat to the health of the American

public and cannot be tolerated.”

FDA Warns of NuVision Contamination!

Connecticut health care providers are being urged by the FDA to cease using sterile products from NuVision Pharmacy. The FDA discovered poor sterilization practices being used by NuVision Pharmacy during an inspection that took place in April. Due to the findings of the inspection, the FDA has called upon the pharmaceutical manufacturer to issue a recall for all their sterile products that have not yet passed their expiration dates.


The FDA believes the products made by NuVision Pharmacy may be dangerous and defective drugs due to their possible lack of sterility. According to the FDA, if drugs that are marketed as sterile actually contain a microbial contamination, patients who are given the drugs may be at risk of infection, which can be life-threatening in some cases. The drug manufacturer has repeatedly declined to issue a recall for their sterile products.


Since the FDA does not have the authority to demand a recall of products from NuVision Pharmacy, the manufacturer is not required to do so. However, to deal with the issue, the FDA has called upon health care providers to stop using products labeled sterile by the company. So far, NuVision Pharmacy is not aware of any adverse events related to their sterilized products, but they did end up recalling two other drugs earlier in the year due to sterility concerns. Individuals who have been injected with products made by the company should contact their health care provider if they have any concerns.