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Valued Contributor
Posts: 645
Registered: ‎03-10-2010

For those on Lipitor: 

 

Statin Medication Recall
April 13, 2017


Several lots of atorvastatin calcium (Lipitor) tablets (10 mg, 20 mg, 40 mg, and 80 mg) are being recalled, the US Food and Drug Administration (FDA) announced in its Enforcement Report for the week of April 5, 2017.
The recalls affect more than 2.4 million bottles and more than 1500 cartons of the prescription statin medication that were distributed throughout the United States and Puerto Rico.
Mylan Pharmaceuticals Inc is voluntarily recalling 90- and 500-count bottles of atorvastatin calcium tablets 10 mg, 20 mg, 40 mg, and 80 mg; and Mylan Institutional Inc (d.b.a. UDL Laboratories) is voluntarily recalling atorvastatin calcium tablets 10 mg, sold as 100-count unit dose tablets (10 x 10) per carton.
The FDA report lists the reason for the recalls as, “Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.”
The code information, including National Drug Codes (NDCs), lot numbers, and expiration dates, for the recalled products are as follows:
Atorvastatin calcium tablets, 10 mg (1,233,107 bottles recalled)

90-count bottles (NDC 0378-3950-77): lot numbers 3076141 and 3076142 (expiration date, 05/18); lot number 2007223 (expiration date, 06/18); lot number 2007335 (expiration date, 07/18); lot number 2007336 (expiration date, 08/18); lot numbers 2007446 and 3084691 (expiration date, 09/18); and lot number 3084692 (expiration date, 01/18)
90-count bottles (NDC 0378-3950-09): lot number 3073773 (expiration date, 01/18) and lot number 2007445 (expiration date, 09/18)
500-count bottles (NDC 0378-3950-05): lot numbers 3076139, 3076140, and 3076143 (expiration date, 05/18); lot numbers 3076144 and 3076145 (expiration date, 06/18); and lot number 2007445 (expiration date, 09/18)
500-count bottles (NDC 0378-3950-07): lot number 3070837 (expiration date, 10/17); lot number 3073773 (expiration date, 01/18); lot number 3076139 (expiration date, 05/18); lot number 3073774 (expiration date, 01/18); and lot number 2007445 (expiration date, 09/18)
Atorvastatin calcium tablets, 20 mg (299,112 bottles recalled)
90-count bottles (NDC 0378-3951-09): lot number 3073776 (expiration date, 01/18); lot numbers 3073777 and 3074909 (expiration date, 02/18); lot numbers 3075564 and 3075565 (expiration date, 03/18); and lot number 2007338 (expiration date, 08/18)
500-count bottles (NDC 0378-3951-07): lot number 3070838 (expiration date, 10/17); lot number 3073775 (expiration date, 01/18); lot numbers 3074908 and 3074909 (expiration date, 02/18); lot number 3075564 (expiration date, 03/18); lot numbers 2007224 and 3075887 (expiration date, 06/18); and lot numbers 2007337 and 2007338 (expiration date, 08/18)
Atorvastatin calcium tablets, 40 mg (444,201 bottles recalled)
90-count bottles (NDC 0378-3952-09): lot numbers 3073779 and 3073780 (expiration date, 02/18); lot number 3074910 (expiration date, 03/18); lot number 3075568 (expiration date, 04/18); lot numbers 3075889 and 3075890 (expiration date, 06/18); lot numbers 2007339 and 2007340 (expiration date, 08/18); and lot numbers 3079881 and 3079882 (expiration date, 10/18)
500-count bottles (NDC 0378-3952-07): lot number 3070839 (expiration date, 10/17); lot numbers 3073778 and 3073779 (expiration date, 02/18); lot numbers 3075566 and 3075567 (expiration date, 04/18); lot numbers 3075890 and 2007225 (expiration date, 06/18); lot number 2007340 (expiration date, 08/18); and lot numbers 3079880 and 3079881 (expiration date, 10/18)
Atorvastatin calcium tablets, 80 mg (452,269 bottles recalled)
90-count bottles (NDC 0378-3953-09): lot numbers 3073782 and 3073783 (expiration date, 02/18); lot numbers 3074915, 3074916, and 3074917 (expiration date, 03/18); lot numbers 3074918 and 3075572 (expiration date, 04/18); lot numbers 3075573 and 3075574 (expiration date, 05/18); lot numbers 2007226 and 3075894 (expiration date, 06/18); lot numbers 2007344, 2007345, and 2007346 (expiration date, 08/18); and lot numbers 2007451, 2007452, 2007453, and 2007454 (expiration date, 09/18)
500-count bottles (NDC 0378-3953-07): lot number 3070840 (expiration date, 10/17); lot numbers 3073781 and 3074911 (expiration date, 02/18); lot numbers 3074912, 3074913, and 3074914 (expiration date, 03/18); lot numbers 3075570 and 3075571 (expiration date, 04/18); lot number 3075892 (expiration date, 05/18); lot number 3075893 (expiration date, 06/18); lot numbers 2007341, 2007342, 2007343, and 2007347 (expiration date, 08/18); and lot number 2007456 (expiration date, 10/18)
Atorvastatin calcium tablets, 10 mg (1527 cartons recalled)
100-count unit dose tablets (10 x 10) per carton (NDC 51079-208-20): lot number 3084288 (expiration date, 07/18)
The recalls were initiated on March 20, 2017, and March 21, 2017. They are still in progress. The FDA gave the recalls Class II designations on March 28, 2017.
Atorvastatin calcium tablets have several indications, including to lower the risk of myocardial infarction (MI), stroke, or revascularization procedures and angina in adults who do not have clinically evident coronary heart disease (CHD) but have multiple risk factors for CHD.  
—Meredith Edwards White

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Honored Contributor
Posts: 12,843
Registered: ‎11-16-2014

@CatLoverDogsToo.....thank you so very much. I called our pharmacist and I am giving him a print-out of this valuable information. He did not seem to know about it and since I had to go back on this med after a too high cholesterol, I have been taking it now for months.....same lot number in the 10mg 90 day supply. Thankfully, CVS is open tomorrow so he can give me a new prescription of it.

Honored Contributor
Posts: 41,534
Registered: ‎03-12-2010

@CatLoverDogsToo

 

Thank you for this.  As someone who has been fighting to control her cholesterol (borderline high) for the past 3 years, I was thinking about giving up the fight and just taking a pill.

 

 

Not now, lol.

There are many elements: wind, fire, water
But none quite like the element of surprise
Respected Contributor
Posts: 3,605
Registered: ‎07-11-2010

@Bird mama....have you tried any natural supplements? There are several different ones that I have tried over the years until I found one that truly showed positive results. 

 

I promise to remind myself every day that I am strong, courageous, and resilient.
Super Contributor
Posts: 278
Registered: ‎05-03-2016

@CatLoverDogsToo wrote:

For those on Lipitor: 

 

Statin Medication Recall
April 13, 2017


Several lots of atorvastatin calcium (Lipitor) tablets (10 mg, 20 mg, 40 mg, and 80 mg) are being recalled, the US Food and Drug Administration (FDA) announced in its Enforcement Report for the week of April 5, 2017.
The recalls affect more than 2.4 million bottles and more than 1500 cartons of the prescription statin medication that were distributed throughout the United States and Puerto Rico.
Mylan Pharmaceuticals Inc is voluntarily recalling 90- and 500-count bottles of atorvastatin calcium tablets 10 mg, 20 mg, 40 mg, and 80 mg; and Mylan Institutional Inc (d.b.a. UDL Laboratories) is voluntarily recalling atorvastatin calcium tablets 10 mg, sold as 100-count unit dose tablets (10 x 10) per carton.
The FDA report lists the reason for the recalls as, “Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.”
The code information, including National Drug Codes (NDCs), lot numbers, and expiration dates, for the recalled products are as follows:
Atorvastatin calcium tablets, 10 mg (1,233,107 bottles recalled)

90-count bottles (NDC 0378-3950-77): lot numbers 3076141 and 3076142 (expiration date, 05/18); lot number 2007223 (expiration date, 06/18); lot number 2007335 (expiration date, 07/18); lot number 2007336 (expiration date, 08/18); lot numbers 2007446 and 3084691 (expiration date, 09/18); and lot number 3084692 (expiration date, 01/18)
90-count bottles (NDC 0378-3950-09): lot number 3073773 (expiration date, 01/18) and lot number 2007445 (expiration date, 09/18)
500-count bottles (NDC 0378-3950-05): lot numbers 3076139, 3076140, and 3076143 (expiration date, 05/18); lot numbers 3076144 and 3076145 (expiration date, 06/18); and lot number 2007445 (expiration date, 09/18)
500-count bottles (NDC 0378-3950-07): lot number 3070837 (expiration date, 10/17); lot number 3073773 (expiration date, 01/18); lot number 3076139 (expiration date, 05/18); lot number 3073774 (expiration date, 01/18); and lot number 2007445 (expiration date, 09/18)
Atorvastatin calcium tablets, 20 mg (299,112 bottles recalled)
90-count bottles (NDC 0378-3951-09): lot number 3073776 (expiration date, 01/18); lot numbers 3073777 and 3074909 (expiration date, 02/18); lot numbers 3075564 and 3075565 (expiration date, 03/18); and lot number 2007338 (expiration date, 08/18)
500-count bottles (NDC 0378-3951-07): lot number 3070838 (expiration date, 10/17); lot number 3073775 (expiration date, 01/18); lot numbers 3074908 and 3074909 (expiration date, 02/18); lot number 3075564 (expiration date, 03/18); lot numbers 2007224 and 3075887 (expiration date, 06/18); and lot numbers 2007337 and 2007338 (expiration date, 08/18)
Atorvastatin calcium tablets, 40 mg (444,201 bottles recalled)
90-count bottles (NDC 0378-3952-09): lot numbers 3073779 and 3073780 (expiration date, 02/18); lot number 3074910 (expiration date, 03/18); lot number 3075568 (expiration date, 04/18); lot numbers 3075889 and 3075890 (expiration date, 06/18); lot numbers 2007339 and 2007340 (expiration date, 08/18); and lot numbers 3079881 and 3079882 (expiration date, 10/18)
500-count bottles (NDC 0378-3952-07): lot number 3070839 (expiration date, 10/17); lot numbers 3073778 and 3073779 (expiration date, 02/18); lot numbers 3075566 and 3075567 (expiration date, 04/18); lot numbers 3075890 and 2007225 (expiration date, 06/18); lot number 2007340 (expiration date, 08/18); and lot numbers 3079880 and 3079881 (expiration date, 10/18)
Atorvastatin calcium tablets, 80 mg (452,269 bottles recalled)
90-count bottles (NDC 0378-3953-09): lot numbers 3073782 and 3073783 (expiration date, 02/18); lot numbers 3074915, 3074916, and 3074917 (expiration date, 03/18); lot numbers 3074918 and 3075572 (expiration date, 04/18); lot numbers 3075573 and 3075574 (expiration date, 05/18); lot numbers 2007226 and 3075894 (expiration date, 06/18); lot numbers 2007344, 2007345, and 2007346 (expiration date, 08/18); and lot numbers 2007451, 2007452, 2007453, and 2007454 (expiration date, 09/18)
500-count bottles (NDC 0378-3953-07): lot number 3070840 (expiration date, 10/17); lot numbers 3073781 and 3074911 (expiration date, 02/18); lot numbers 3074912, 3074913, and 3074914 (expiration date, 03/18); lot numbers 3075570 and 3075571 (expiration date, 04/18); lot number 3075892 (expiration date, 05/18); lot number 3075893 (expiration date, 06/18); lot numbers 2007341, 2007342, 2007343, and 2007347 (expiration date, 08/18); and lot number 2007456 (expiration date, 10/18)
Atorvastatin calcium tablets, 10 mg (1527 cartons recalled)
100-count unit dose tablets (10 x 10) per carton (NDC 51079-208-20): lot number 3084288 (expiration date, 07/18)
The recalls were initiated on March 20, 2017, and March 21, 2017. They are still in progress. The FDA gave the recalls Class II designations on March 28, 2017.
Atorvastatin calcium tablets have several indications, including to lower the risk of myocardial infarction (MI), stroke, or revascularization procedures and angina in adults who do not have clinically evident coronary heart disease (CHD) but have multiple risk factors for CHD.  
—Meredith Edwards White


Do you know if this includes the generic version of the medication? Was there a reason given for the recall? Thank you so much for posting this!

Honored Contributor
Posts: 41,534
Registered: ‎03-12-2010

@catwhisperer   I control the LDL with diet and cholest-off plus.  My triglycerides are perfect.  The latest gripe was my HDL dropped.  So, I am doing flax seed and more good fats plus a low dosage Niacin supplement once a day.

 

I'm post menopausal, don't take HRT and have a underactive thyroid, lol.

 

I continue to fight the good fight, lol.

There are many elements: wind, fire, water
But none quite like the element of surprise
Honored Contributor
Posts: 13,913
Registered: ‎03-10-2010

 

@Mermaid22

 

Atorvastatin is a Generic. It is the Generic of Lipitor. I have been taking this Generic since it first became available. I was put on Lipitor after my 1st heart attack in 2003, and been on 1 or the other since.

 

I get mail order 90 tabs, so I am going to check my bottle and the numbers given by the one that gave is this valuable info. 

 

 

 

hckynut(john)

 

 

hckynut(john)
Honored Contributor
Posts: 13,913
Registered: ‎03-10-2010

 

@CatLoverDogsToo

 

Thank you for this very important information. I have been taking Atorvastatin since it was available in lieu of Lipitor. I am going to check my numbers against what you have posted and go from there.

 

Mine are mail order from Express Scripts, and 90 day bottles. Seems like I just got my refill recently.

 

Thank you very much for this post. It certainly might effect me. If my numbers line up, maybe even if they don't, I will call Express Scripts in the morning and see what the have to say. Next will be my doctor on Monday.

 

 

 

hckynut(john)

hckynut(john)
Honored Contributor
Posts: 8,808
Registered: ‎06-10-2010

Yes, thanks for posting this.  DH takes this and he certainly doesn't need any more problems right now. I checked his out and his is ok. 

Honored Contributor
Posts: 12,997
Registered: ‎03-25-2012

I hope all the doctors with stockpiles of this med in their offices will take heed.  I'm sure the pharmacists will.

 

My total cholesterol is low to mid 200's.  However, my HDL is very high, and my trys are low.  Ratios are good.  Have been prescribed statins many times . . . and have never taken it. 

 

Thanks for the heads up, @CatLoverDogsToo.

Formerly Ford1224
We must always take sides. Neutrality helps the oppressor, never the victim. Silence encourages the tormentor, never the tormented. Elie Wiesel 1986