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“Your Quality Unit has failed in the responsibility and authority to monitor Quality Systems designed to assure the quality of drug products manufactured and packaged at your firm.”

FDA to Novartis Consumer Health (Lincoln, Nebraska), July 8, 2011

On July 8, 2011, FDA completed an inspection of Novartis Consumer Health (Lincoln, Nebraska), and handed the company a report (Form 483) listing 13 separate “Observations” relating to deficiencies in Novartis’ quality assurance and complaint handling systems.

About one month later, Giant® Food Stores notified its customers that Novartis had recalled Excedrin Extra Strength Caplets, 100-count (Lot #10068948; Expiration date March 31, 2010), “as a result of instances of product mix-ups found in the lot” (posted on eFoodAlert September 7, 2011).

On November 1, 2011, Giant® Food Stores warned its customers of another Novartis recall – Excedrin – Pain Reliever Acetaminophen Adult, 100 CO (Lot #10087530; Expiration date 3/31/2013). Again, the recall was due to product mix-up occurrences in the lot. That same day, Food City posted a recall notice for three Novartis products, including Excedrin Extra Strength Caplets 24 countExcedrin Migraine Caplets 24 count, and Excedrin Floorstand ES Migraine with $1 IRC. More retailers chimed in the following day, and a consolidated list of recalled lots was provided on eFoodAlert’s Recalls and Alerts: November 2, 2011.

Today (January 8, 2012), in an unusual Sunday announcement, Novartis Consumer Health, Inc. issued a News Release detailing the recall of “…all lots of select bottle packaging configurations of Excedrin® and NoDoz® products with expiry dates of December 20, 2014 or earlier as well as Bufferin® and Gas-X Prevention® products with expiry dates of December 20, 2013 or earlier, in the United States. NCH is taking this action as a precautionary measure because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets.”

Am I being silly, or is it just possible that FDA’s posting on January 5th of the July 8, 2011 Novartis Inspectional “Observations” Report might be somehow tied into this sudden decision by Novartis to go public?

Here are just a few excerpts from the report. These are direct quotations. Read them and decide for yourself.

  • You have failed to open deviation investigations into numerous “critical” consumer complaints of foreign products found inside the drug products manufactured at your firm.
  • You have failed to adequately investigate 166 complaint instances of foreign tablets in your drug products since 2009.
  • You have failed to extend investigations to all batches of product potentially affected by a problem.
  • You have received numerous consumer complaints which were not submitted to the FDA as required by your firm’s procedures.
  • Your Quality Assurance review of critical foreign tablet complaint investigations (Technical Complaint Investigation Reports) is not occurring in a timely manner… There are approximately 138 reports that took over 100 days to review.
  • You have failed to identify the root cause of customer complaints for solid dosage form foreign tablets of products manufactured at your firm since at least 2009.
  • Your Unplanned Deviation Reports are deficient in that conclusions drawn are not supported by the evidence in the reports.
  • Your Quality Assurance Unit has consistently failed to review critical complaints for drug products manufactured and packaged at your facility. For example [for 2011], 223 critical complaints have not been properly reviewed out of 223 critical complaints received by your firm… Also, your Quality Assurance review of critical complaints ceased in mid-October 2010. This deficiency was unnoticed by your Quality Unit until this FDA inspection.

The entire report is 13 pages long. It details lapses in procedure, in judgment, and in training.

In addition to the recall, Novartis advises that its Lincoln, NE facility “…has voluntarily suspended operations and shipments to accelerate maintenance and other improvement activities at the site.”

I have to ask – WHAT TOOK SO LONG?

Novartis has promised to have a dedicated web page (www.novartisOTC.com) in operation by January 9th to provide consumers with detailed information on its newly announced recall. The complete list of recalled products follows:

  • Bufferin® Extra Strength Tablets 130CT: UPC 300672065131
  • Bufferin® Extra Strength Tablets 39CT: UPC 300672065391
  • Bufferin® Low Dose Tablets 130CT: UPC 300676424132
  • Bufferin® Regular Strength Tablets 130CT: UPC 300672063137
  • Excedrin® Back & Body Caplets 100CT Account Specific: UPC
  • 300676238920
  • Excedrin® Back & Body Caplets 100CT Account Specific No Carton: UPC 300676238944
  • Excedrin® Back & Body Caplets 100CT New Label: UPC 300676238913
  • Excedrin® Back & Body Caplets 24CT New Label: UPC
  • 300676238241
  • Excedrin® Back & Body Caplets 50CT New Label: UPC
  • 300676238500
  • Excedrin® Extra Strength Caplets 100CT Account Specific: UPC 300672000927
  • Excedrin® Extra Strength Caplets 100CT Account Specific: UPC 300672000941
  • Excedrin® Extra Strength Caplets 100CT Account Specific: UPC 300672000941
  • Excedrin® Extra Strength Caplets 100CT Account Specific: UPC 300672000910
  • Excedrin® Extra Strength Caplets 100CT: UPC 300672000910
  • Excedrin® Extra Strength Caplets 125CT Bonus Pack: UPC 300672000835
  • Excedrin® Extra Strength Caplets 125CT Bonus Pack Account Specific: UPC 300672000842
  • Excedrin® Extra Strength Caplets 125CT New Carton: UPC 300672000866
  • Excedrin® Extra Strength Caplets 24+6CT Bonus Pack: UPC 300672000309
  • Excedrin® Extra Strength Caplets 24CT: UPC 300672000248
  • Excedrin® Extra Strength Caplets 24CT New Label: UPC 300672000248
  • Excedrin® Extra Strength Caplets 250CT No Carton: UPC 300672000071
  • Excedrin® Extra Strength Caplets 250CT No Carton New Label: UPC 300672000071
  • Excedrin® Extra Strength Caplets 250CT Special Inner: UPC 300672000774
  • Excedrin® Extra Strength Caplets 250CT New Label: UPC 300672000774
  • Excedrin® Extra Strength Caplets 300CT Bonus Pack: UPC 300672000552
  • Excedrin® Extra Strength Caplets 50CT New Label: UPC 300672000507
  • Excedrin® Extra Strength Caplets 50S: UPC 300672000507
  • Excedrin® Extra Strength Express Gel Caps 20CT New Label: UPC 300676270203
  • Excedrin® Extra Strength Express Gel Caps 40CT New Label: UPC 300676270401
  • Excedrin® Extra Strength Express Gel Caps 80CT Account Specific: UPC 300676270814
  • Excedrin® Extra Strength Express Gel Caps 80CT: UPC 300676270807
  • Excedrin® Extra Strength Express Gel Caps 80CT Account Specific: UPC 300676270944
  • Excedrin® Extra Strength Gel Tablets 24CT: UPC 300672021243
  • Excedrin® Extra Strength Tablets 100CT Special Inner: UPC
  • 300672030917
  • Excedrin® Extra Strength Tablets 100CT Account Specific: UPC 300672030931
  • Excedrin® Extra Strength Tablets 100CT Account Specific: UPC 300672030948
  • Excedrin® Extra Strength Tablets 100CT New Label: UPC 300672030917
  • Excedrin® Extra Strength Tablets 125CT Bonus Pack: UPC 300672030832
  • Excedrin® Extra Strength Tablets 125CT Bonus Pack New Carton: UPC 300672030863
  • Excedrin® Extra Strength Tablets 200CT New Label: UPC 300672030924
  • Excedrin® Extra Strength Tablets 24+6CT Bonus Pack: UPC 300672030306
  • Excedrin® Extra Strength Tablets 24CT: UPC 300672030245
  • Excedrin® Extra Strength Tablets 24CT New Label: UPC 300672030245
  • Excedrin® Extra Strength Tablets 250+50CT Bonus Pack: UPC 300672030573
  • Excedrin® Extra Strength Tablets 250CT No Carton: UPC 300672030078
  • Excedrin® Extra Strength Tablets 250CT No Carton New Label: UPC 300672030078
  • Excedrin® Extra Strength Tablets 250CT Special Inners: UPC 300672030771
  • Excedrin® Extra Strength Tablets 250CT New Label: UPC 300672030771
  • Excedrin® Extra Strength Tablets 300CT New Carton: UPC 300672030337
  • Excedrin® Extra Strength Tablets 300CT Club Tray: UPC 300672030337
  • Excedrin® Extra Strength Tablets 300CT New Label: UPC 300672030337
  • Excedrin® Extra Strength Tablets 300S: UPC 300672030337
  • Excedrin® Extra Strength Tablets 50CT: UPC 300672030504
  • Excedrin® Extra Strength Tablets 50CT New Label: UPC 300672030504
  • Excedrin® Extra Strength Tablets 8CT: UPC 300672030085
  • Excedrin® Extra Strength Tablets 8CT New Label: UPC 300672030085
  • Excedrin® Migraine Express Gel Caplets 20CT New Label: UPC 300676341200
  • Excedrin® Migraine Caplets 100CT: UPC 300672039910
  • Excedrin® Migraine Caplets 100CT Account Specific: UPC 300672039941
  • Excedrin® Migraine Caplets 100CT Account Specific No Carton: UPC 300672039941
  • Excedrin® Migraine Caplets 100CT Account Specific: UPC 300672043917
  • Excedrin® Migraine Caplets 100CT New Label: UPC 300672039910
  • Excedrin® Migraine Caplets 125CT Bonus Pack No Carton: UPC 300672039842
  • Excedrin® Migraine Caplets 125CT Bonus Pack New Carton: UPC 300672039866
  • Excedrin® Migraine Caplets 125CT Bonus Pack: UPC 300672039835
  • Excedrin® Migraine Caplets 200CT New Label: UPC 300672039927
  • Excedrin® Migraine Caplets 24+6CT Bonus Pack: UPC 300672039309
  • Excedrin® Migraine Caplets 24CT: UPC 300672039248
  • Excedrin® Migraine Caplets 24CT New Label: UPC 300672039248
  • Excedrin® Migraine Caplets 250+50CT Bonus Pack: UPC 300672039576
  • Excedrin® Migraine Caplets 250CT No Carton: UPC 300672039071
  • Excedrin® Migraine Caplets 250CT No Carton New Label: UPC 300672039071
  • Excedrin® Migraine Caplets 250CT Special Inners: UPC 300672039774
  • Excedrin® Migraine Caplets 250CT New Label: UPC 300672039774
  • Excedrin® Migraine Caplets 300CT: UPC 300672039330
  • Excedrin® Migraine Caplets 300CT New Carton: UPC 300672039330
  • Excedrin® Migraine Caplets 300CT New Label: UPC 300672039330
  • Excedrin® Migraine Caplets 300CT Club Tray: UPC 300672039330
  • Excedrin® Migraine Caplets 50CT New Label: UPC 300672039507
  • Excedrin® Migraine Caplets 50CT: UPC 300672039507
  • Excedrin® Migraine Caplets 8CT New Label: UPC 300672039088
  • Excedrin® Migraine Gel Tablets 160CT: UPC 300672035165
  • Excedrin® Migraine Gel Tablets 100CT Special Inner: UPC 300672035912
  • Excedrin® Migraine Gel Tablets 100CT New Label: UPC 300672035912
  • Excedrin® Migraine Gel Tablets 100CT Account Specific: UPC 300672044914
  • Excedrin® Migraine Gel Tablets 24CT – New Label: UPC 300672035240
  • Excedrin® Migraine Gel Tablets 2X50CT: UPC 300672035936
  • Excedrin® Migraine Gel Tablets 50CT New Label: UPC 300672035509
  • Excedrin® Migraine Tablets 100CT Special Inner: UPC 300672037916
  • Excedrin® Migraine Tablets 100CT New Label: UPC 300672037916
  • Excedrin® Migraine Tablets 125CT Bonus Pack: UPC 300672037831
  • Excedrin® Migraine Tablets 24+6CT Bonus Pack: UPC 300672037305
  • Excedrin® Migraine Tablets 24CT: UPC 300672037244
  • Excedrin® Migraine Tablets 24CT New Label: UPC 300672037244
  • Excedrin® Migraine Tablets 250CT Special Inner: UPC 300672037770
  • Excedrin® Migraine Tablets 250CT New Label: UPC 300672037770
  • Excedrin® Migraine Tablets 50CT: UPC 300672037503
  • Excedrin® Migraine Tablets 50CT New Label: UPC 300672037503
  • Excedrin® PM Caplets 100CT New Label: UPC 300672055910
  • Excedrin® PM Caplets 125CT Bonus Pack New Carton: UPC 300672055866
  • Excedrin® PM Caplets 24CT New Label: UPC 300672055248
  • Excedrin® PM Caplets 50CT New Label: UPC 300672055507
  • Excedrin® PM Express Gel Caplets 20CT: UPC 300676405209
  • Excedrin® PM Express Gel Caplets 80CT Account Specific: UPC 300676405810
  • Excedrin® PM Express Gel Caplets 80CT No Carton: UPC 300676409801
  • Excedrin® PM Express Gel Caplets 80CT New Label: UPC 300676405803
  • Excedrin® PM Tablets 100CT Account Specific: UPC 300672053923
  • Excedrin® PM Tablets 100CT Account Specific No Carton: UPC 300672053947
  • Excedrin® PM Tablets 100CT New Label: UPC 300672053916
  • Excedrin® PM Tablets 125CT Bonus Pack: UPC 300672053831
  • Excedrin® PM Tablets 24+6CT Bonus Pack: UPC 300672053305
  • Excedrin® PM Tablets 24CT New Label: UPC 300672053244
  • Excedrin® PM Tablets 50CT New Label: UPC 300672053503
  • Excedrin® PM Tablets 8CT New Label: UPC 300672053084
  • Excedrin® Sinus Headache Caplets 24CT New Label: UPC 300672062246
  • Excedrin® Tension Headache Caplets 100CT Special Inner: UPC 300672045911
  • Excedrin® Tension Headache Caplets 100CT Account Specific No Carton: UPC 300672045942
  • Excedrin® Tension Headache Caplets 100CT Account Specific No Carton New Label: UPC 300672045942
  • Excedrin® Tension Headache Caplets 100CT Account Specific: UPC 300672045959
  • Excedrin® Tension Headache Caplets 100CT New Label: UPC 300672045911
  • Excedrin® Tension Headache Caplets 125CT Bonus Pack: UPC 300672045836
  • Excedrin® Tension Headache Caplets 125CT Bonus Pack No Carton: UPC 300672045843
  • Excedrin® Tension Headache Caplets 24+6CT Bonus Pack: UPC 300672045300
  • Excedrin® Tension Headache Caplets 24CT Special Inner: UPC 300672045249
  • Excedrin® Tension Headache Caplets 24CT New Label: UPC 300672045249
  • Excedrin® Tension Headache Caplets 250CT: UPC 300672045775
  • Excedrin® Tension Headache Caplets 250CT No Carton: UPC 300672045072
  • Excedrin® Tension Headache Caplets 50CT Special Inner: UPC 300672045508
  • Excedrin® Tension Headache Caplets 50CT New Label: UPC 300672045508
  • Excedrin® Tension Headache Express Gel Caplets 20CT: UPC 300676272207
  • Excedrin® Tension Headache Express Gel Caplets 40CT: UPC 300676272405
  • Excedrin® Tension Headache Express Gel Caplets 80CT Account Specific: UPC 300676272948
  • Excedrin® Tension Headache Express Gel Caplets 80CT: UPC 300676272801
  • Excedrin® Tension Headache Gel Tablets 24CT New Label: UPC 300672050243
  • Gas-X® Prevention® Caplets 20CT: UPC 300433005208
  • Gas-X® Prevention® Caplets 50CT: UPC 300433005505
  • NoDoz® Maximum Strength Caplets 16CT: UPC 300672070166
  • NoDoz® Maximum Strength Caplets 16CT New Graphic: UPC 300672070166
  • NoDoz® Maximum Strength Caplets 36CT: UPC 300672070364
  • NoDoz® Maximum Strength Caplets 36CT New Graphic: UPC
  • 300672070364
  • NoDoz® Maximum Strength Caplets 60CT: UPC 300672070609
  • NoDoz® Maximum Strength Caplets 60CT New Graphic: UPC 300672070609

The recall encompasses all production lots of these products distributed in the USA. In addition, two of the recalled products – Excedrin Extra Strength Caplets and Excedrin Tension Headache Caplets – were exported to Canada. Following is a list of retail supermarkets and pharmacies in the USA and Canada who stocked the recalled products (updated January 17, 2012):

  • Acme: Excedrin, Bufferin, NoDoz & Gas-X Prevention
  • Albertsons: Excedrin, Bufferin, NoDoz & Gas-X Prevention
  • Big Y: Excedrin and Gas-X
  • Buehler’s Fresh Foods: Excedrin, Bufferin, GasX and NoDoz
  • Copps: All lot codes of Excedrin, Bufferin, No-Doze and Gas-X Prevention
  • Costco: Excedrin products (Costco Item ##720393,#672030, #146557, #618236, and #6189) sold on or after January 8, 2009
  • Costco Canada: Excedrin Extra Strength Caplets and Excedrin Tension Headache Caplets (All expiration dates up to and including December 20, 2014)
  • D&W Fresh Market: Bufferin and Excedrin products
  • Family Fare Supermarkets: Bufferin and Excedrin products
  • Food City: Assorted Excedrin, No Doz, Bufferin & Gas-X Items
  • Giant Eagle: Bufferin, Excedrin, Gas-X and NoDoz
  • Giant® Food Stores: Excedrin, Bufferin, No Doz & Gas-X
  • The Kroger Company (including Kroger, King Soopers, City Market, Jay C, Dillons, Baker’s Gerbes, Fry’s, Food4Less, Food4Less Fremont, FoodsCo, Ralphs, Fred Meyer, Smith’s and QFC stores): Bufferin, Excedrin, No Doz and Gas-X
  • Glen’s: Bufferin and Excedrin products
  • Glen’s Fresh Market: Bufferin and Excedrin products
  • H-E-B: Bufferin, Excedrin, Gas-X Prevention and NoDoz
  • Mariano’s Fresh Market: All lot codes of Excedrin, Bufferin, No-Doze, Gas-X
  • Metro Market: All lot codes of Excedrin, Bufferin, No-Doze, Gas-X
  • Pick ‘n Save: All lot codes of Excedrin, Bufferin, No-Doze, Gas-X
  • Price Chopper: Excedrin, Bufferin, GasX, No Doz
  • Publix: Excedrin, Gas-X, Bufferin and No-Doz
  • Rainbow: All lots of Excedrin, Bufferin, No-Doze, Gas-X
  • Rite Aid: Bufferin, Excedrin, Gas-X Prevention and NoDoz products
  • Schnucks: (including Schnucks, Logli and Hilander stores): Excedrin, Bufferin, NoDoz and Gas-X Prevention
  • ShopRite: Bufferin, Excedrin, NoDoz and Gas-X Prevention products
  • Spartan: Bufferin and Excedrin products
  • Target: Excedrin and Gas-X Prevention products
  • Top Food & Drug: Excedrin and Bufferin products
  • Valu Land: Bufferin and Excedrin products
  • VG’s Fresh Market: Bufferin and Excedrin products
  • VG’s Grocery: Bufferin and Excedrin products
  • Walgreens: Provides link to recall notice on FDA site
  • Walmart (including Walmart and Sam’s Club stores): Excedrin, N0Doz, Bufferin and Gas-X Prevention products
  • Wegmans: Bufferin, Excedrin, Gas-X Prevention and NoDoz products
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