Ranbaxy Recalls Generic Lipitor (Atorvastatin)

Ranbaxy Pharmaceuticals Inc. has initiated a recall of certain batches and strengths of Atorvastatin calcium tablets – the company’s generic version of Lipitor. The recall only affect products distributed in the United States.

The recall notice posted on Ranbaxy’s web site reads as follows:

Atorvastatin Recall

Ranbaxy Pharmaceuticals Inc. is conducting a voluntary recall only in the U.S. healthcare system for select batches and strengths of Atorvastatin calcium tablets. The recall is in connection with its 10mg 20mg and 40mg dosage strengths, packaged in 90’s and 500 count bottles, and only with respect to certain select lot numbers. The recall does not affect or relate to the 80mg strength or any other Ranbaxy Product in any other market.

The recall is being conducted in the U.S. at the retail level for such select batches that may contain a foreign substance (small glass particles approximately less than 1mm in size). Ranbaxy is proactively recalling the drug product lots out of an abundance of caution, and in keeping the safety of our customers in mind. This recall is being conducted with the full knowledge of the U.S. FDA. The recall is limited to the U.S. market only and affects specific lots numbers and strengths of this molecule manufactured by Ranbaxy only for sale in the U.S.

Atorvastatin calcium tablets or any other product containing this molecule distributed outside the US is not affected in any way by this recall. The activities taking place in the U.S. will not affect Ranbaxy’s ability to continue to supply product in any other markets.

Individuals who have been prescribed atorvastatin calcium in the 10mg, 20mg or 40mg dosage strengths should refer to the list of recalled products supplied by Ranbaxy, and should contact their pharmacist for additional instructions.

Three of Ranbaxy’s manufacturing facilities have been operating under a consent decree of permanent injunction, filed by the US Department of Justice in January 2012. The consent decree addressed “…outstanding current good manufacturing practice (CGMP) and data integrity issues at Ranbaxy’s Paonta Sahib, Batamandi and Dewas, India facilities as well as CGMP issues at Ranbaxy Inc.’s wholly owned subsidiary Ohm Laboratories facility located in Gloversville, N.Y.” When queried by eFoodAlert today about this recall, Sarah Clark-Lynn of FDA’s Office of Public Affairs responded with the following statement:

First, let me say that consumers in this country expect and deserve safe, effective, and high quality medications. The FDA is working with the company to address their quality issues.

Product from the affected lots of atorvastatin (see Ranbaxy’s website for the lot numbers) may have been dispensed to patients and may have already been consumed. Patients concerned about the product they have on hand should contact their pharmacist and consult with their physician.

The FDA is currently working with other manufacturers to address any potential shortage as a result of the ongoing recall. We will continue to monitor this situation.

The Ranbaxy facilities involved in manufacturing atorvastatin were not the same facilities whose conduct gave rise to the consent decree. Nonetheless, the consent decree provides the FDA with additional tools to address violations for other Ranbaxy facilities.

The evaluation of this quality issue is ongoing.

FDA Confirms Salmonella Outbreak Strain At Sunland Facility

FDA announced today (October 13th) that it has confirmed a genetic match between the strain of Salmonella Bredeney that has sickened 35 persons and the strain that the agency recovered from Sunland Inc.‘s nut butter production environment in Portales, New Mexico.

In addition, FDA recovered Salmonella from the environment of a separate building where peanuts are processed, and from raw peanuts sampled in that building. Yesterday, Sunland expanded its previous recalls yet again to include raw and roasted shelled and in-shell peanuts. The company has ceased production and distribution of all products from both its nut butter facility and its peanut processing facility.

CDC first reported the outbreak of Salmonella Bredeney illnesses on September 22nd. At that time, epidemiological evidence pointed to Trader Joe’s Valencia Creamy Salted Peanut Butter made with Sea Salt as the likely source of the outbreak. Subsequent tests carried out by the Washington State Department of Agriculture recovered the outbreak strain from an opened jar of Trader Joe’s Valencia Cream Peanut Butter collected from the home of an outbreak victim.Trader Joe’s peanut and other nut butter products are manufactured by Sunland, Inc.

As of October 5th, 35 outbreak illnesses were confirmed in 19 states; eight people hospitalized; no deaths. Illness onset dates range from June 14, 2012 to September 18, 2012. Illnesses were reported by Arizona (1), California (5), Connecticut (3), Illinois (1), Louisiana (1), Massachusetts (3), Maryland (1), Michigan (1), Minnesota (1), Missouri (2), Nevada (1), New Jersey (2), New York (1), North Carolina (1), Pennsylvania (2), Rhode Island (1), Texas (5), Virginia (1), and Washington (2).

Here’s what FDA had to say today:

The FDA announced that on October 12, Sunland Inc. expanded its ongoing recall to include raw and roasted shelled and in-shell peanuts sold in quantities from 2 ounces to 50 pounds which are within their current shelf life or have no stated expiration date.

Since late September, the FDA, the Centers for Disease Control and Prevention and state and local public health officials have been investigating a multi-state outbreak of Salmonella Bredeney infections linked to a peanut butter made by Sunland Inc. As part of the continuing investigation, the FDA has been inspecting the Sunland Inc. production facilities, including a building in which peanuts are processed and a separate building in which nut butters are made. FDA testing has found the presence of Salmonella in raw peanuts from the peanut processing facility. Environmental samples taken from this building also show the presence of Salmonella. Environmental samples are samples taken from various surfaces in the production or manufacturing facility that would likely harbor bacteria.

Additionally, FDA analysis has confirmed that environmental samples showing the presence of Salmonella in Sunland’s nut butter facility have a DNA fingerprint that is the same as the outbreak strain of Salmonella Bredeney.

Sunland Inc. reports that it has ceased the production and distribution of all products from both its nut butter facility and its peanut processing facility.

Sunland raw and roasted peanuts available to retail customers are distributed primarily under the company’s own label and were distributed primarily to produce houses and nationally to numerous large supermarket, grocery and retail chains. The products also were available for purchase on the internet.

A list of all products being recalled by Sunland Inc. can be found in the company’s recall announcement.

Consumers should not eat the recalled products. This is especially important for children under the age of 5 years, elderly adults, and people with weak immune systems.

The latest recall expansion already is triggering an additional series of secondary and tertiary recalls as Sunland’s customers scramble to pull foods containing the recalled peanuts and nut butters off the market. eFoodAlert’s Trader Joe’s/Sunland Peanut Butter Recall page will be updated to reflect the additional recalls.

Tenderized Beef Sickens 4 In Canada

Four Edmontonians became ill with E. coli O157:H7 after consuming Kirkland brand Strip Loin Grilling Steaks purchased from Costco Wholesale store #156 in Edmonton, Alberta. The beef originated from XL Foods processing plant in Brooks, Alberta.

CBC News reports that Alberta Health Services confirmed the connection after testing a steak provided by one of the outbreak victims. Officials are suggesting that the pathogen may have been introduced into the meat during a tenderizing process that is used by Costco stores in Alberta.

The steaks implicated in the four illnesses were identified by the Canadian Food Inspection Agency as Strip Loin Grilling Steak prepared and sold in variable weight packages from Costco Wholesale store #156, located at 13650, 50th street, Edmonton, Alberta, bearing Packed On dates 12/SE/04, 12/SE/05, 12/SE/06 or 12/SE/07. At the moment, only steaks from this one Costco store are affected.

No direct link has been established between the illnesses and the XL Foods plant that supplied the beef.

XL Food’s Brooks processing facility is the source of meat that has been under a steadily expanding series of recall notices across Canada, and a series of Public Health Alerts in the USA. The USDA’s Food Safety and Inspection Service detected E. coli O157:H7 in beef trimmings from XL Foods that were shipped from Canada to the USA.

There is no indication, either in the CBC report or from the Canadian Food Inspection Agency, as to whether the outbreak strain recovered from the steak in Edmonton is the same as the strain of E. coli O157:H7 found in XL’s beef trimmings.

For a consolidated list of beef products affected by the XL Foods recall, and information on retail distribution in Canada and the USA, please consult the Canada/USA Beef Recall tab.