Author: Phyllis Entis

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.

Recalls and Alerts: November 26, 2012

Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

If you would like to receive automatic email alerts for all new articles posted on eFoodAlert, please submit your request using the sidebar link.

For current information on international and retail distribution of peanut butter products recalled due to Salmonella Bredeney, please consult the Trader Joe’s/Sunland Peanut Butter Recalls tab.

United States

  • Allergy Alert: Legendary Baking (Denver, CO) recalls Private Selection Apple Lattice Pies (9-inch; UPC 1111060195; Lot code 12296; Sell by dates November 4 – 26, 2012, inclusive), because the pies may contain undeclared eggs. The recalled pies were distributed to Quality Food Centers in Washington State and Oregon.
  • Allergy Alert: Newman’s Own, Inc. recalls Newman’s Own Lite Honey Mustard Dressing (16 fl oz bottles; Sell by 16 OCT 13 M; Time stamp 12:47 – 13:30; UPC 0 20662 00292 1), because the product contains undeclared milk. The recalled dressing was sold in retail stores in the Eastern to Midwestern US.

Canada

  • Allergy Alert: Soloway Hot Dog Factory Inc. recalls all varieties of All Beef Weiner, Soloway’s Weiners, Halal Beef Weiner, Bratwurst Sausages, Soloway’s Supreme Weiners, and Chicken Weiners (all codes where mustard is not declared in the ingredient list), due to the presence of undeclared mustard. The recalled products were distributed to hotels, restaurants and institutions in Ontario.
  • Food Safety Recall: Arla Foods Incorporated recalls Tre Stelle Grated Cheese 100% Parmesan (125g; Best before 2013/JN/01; UPC 0 59441 00428 3), due to microbiological spoilage. the recalled product was sold through retailers in Alberta, British Columbia, New Brunswick, Nova Scotia, Ontario, and Quebec.
  • Personal Care Product Safety Recall: Energizer Personal Care expands its earlier recall of continuous spray sun care products because there is a possibility that these sunscreens could ignite on the skin if the consumer comes into contact with an open flame or spark before the spray has completely dried. The complete list of recalled products includes: Banana Boat Sport Performance 30 Spray Sunscreen (180 mL; UPC 079656008784), Banana Boat Ultra Defense SPF 30 Spray Sunscreen (180 mL; UPC 079656008371), Banana Boat Sunscreen Oil Spray SPF 15 (UPC 079656009798), Banana Boat Ultra Defense SPF 60 Spray (180 mL; UPC 79656 04991-6), and Banana Boat Sport Performance SPF 60 Spray (180 mL; UPC 79656 04990-9).

Europe

  • Food Safety Recall (Germany): Märsch Importhandels GmbH recalls Ground Hazelnuts (200g; Best Before dates 06.06.2013 and 06.07.2013), because the product was found to be contaminated with Salmonella. The recalled product was sold exclusively at Lidl in early September.
  • Outbreak Alert Update (Norway): Public health officials in Norway are reporting 10 cases of salmonellosis due to a single, rare strain of Salmonella Mikawasima.  The patients all are adults (aged 20-50 years), and live in six different counties (Akershus Aust-Agder, Vest-Agder, Hordaland, Oppland, Oslo and Nordland). The source of the outbreak is still undetermined.

Asia, Africa and the Pacific Islands

Some supermarket chains post recall notices on their web sites for the convenience of customers. To see whether a recalled food was carried by your favorite supermarket, follow the live link to the supermarket’s recall web site.

*The Kroger umbrella encompasses numerous supermarket, marketplace and convenience store chains, listed on the Kroger corporate home page.
**Includes Safeway, Vons, Pavilions, Dominick’s, Genuardi’s, Randalls, Tom Thumb, Carrs and Pak N’ Save.

Prompt Prose: Mardi Gras

Jaimie lay in bed, curled up on her side, feeling miserable. She had arrived in New Orleans the day before – just in time to catch the end of Mardi Gras. “It must be the hangover,” she groaned. “I couldn’t have seen him. He died before I was born.”

She had caught just a glimpse at first – recognized him from pictures that her Mom kept around the house. It was on Bourbon Street, just out front of Preservation Hall – the home of New Orleans jazz. He was beckoning to her, silently imploring her to come with him.

Jaimie tried to follow him, straining to keep him in sight. The kaleidoscope of colors and characters whirled all around – sometimes out of focus, sometimes in shocking clarity. But he was always out there somewhere ahead, leading her onward. “Where are we going?” she wondered.

At first, his movements seemed random; up one street, then down another, weaving through the crowds that went on and on. Then she understood. He was leading her back to her hotel room in the French Quarter. He was taking her away from the crowds. Away from the noise. Away from the groping hands and sloshing cups of beer that splashed her as she struggled to keep up with him.

She had almost caught up with him now. She saw him enter her hotel. And then he vanished. Jaimie went up to her room, half expecting to see him there. But the room was empty – a quiet oasis in the constant chaos known as New Orleans. “Must have been my imagination after all,” she thought. “May as well go to bed. I’m more wasted than I thought.”

And now it was morning. Had she imagined the whole thing? Had her subconscious mind protected her by drawing her back to her room?

“I need some air,” Jaimie thought as she opened the door and stepped onto her balcony. She surveyed the street below, littered with the detritus of last night’s revels: empty beer cups, stray strings of beads, sticky puddles of evaporated beer. A typical morning in the French Quarter.

Then she saw him, standing below, looking up at her – the man she saw last night. The man in the photographs in her Mom’s house. It was Joe. Her long-dead grandfather. Her  protector.

And she knew. Jaimie rushed back into her room, grabbed her cell phone, and hit the speed dial. “Dad,” she stammered, as soon as she heard his voice, “what’s wrong? It’s Mom, isn’t it? Is she going to be OK? Yes, I know she’s worried about me. Tell her I’m safe. I’ll be home tonight.”

©2012 Phyllis Entis. All rights reserved.

A Note of Explanation: The “prompt” for this story was multi-stage. First, each participant was asked to write down one male name and one female name. Then, we each were asked to write down a location – a city, country, or any physical place – on a slip of paper and put the paper into a common envelope. Finally, each of us drew a slip of paper at random from the envelope. Our “prompt” was a combination of the names we had selected and the random location each of us drew from the envelope. The “prompt” for this story became “Joe and Jaimie on a wrought iron balcony in the French Quarter of New Orleans.”