Archive for August, 2011


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http://www.osgata.org/support-osgata

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http://naturalpainreliefforfibromyalgia.com/985

http://naturalpainreliefforfibromyalgia.com/942

 

 

Welcome to Natural Pain Relief for Fibromyalgia

FDA Drug recalls. Do we hear about the recalls or do we just consume the product or have it

injected into us without knowledge? I listed below the FDA recalls so far for 2011.  I then

broke it down to see exactly what is being recalled and why.

 

What I found was potency, contamination, Elizabethkingia meningoseptica bacteria, and mis-

labelling, all from pills, injectibles and hospital paraphernalia such as cotton swabs infection

through catheters. The mis-labeling can be very serious especially when it involves drugs that

can cause liver toxicity. With 650 mg pills in 325 mg bottles, it can be lethal for some.

FDA Recalls so far in 2011, you can check the link at the bottom to find the list.


So lets break it down by company and drugs and have a good look:

1. American Regent Inc. has had 10 recalls already this year:

Injections with Particulates and sub-potency problems

Vasopressin Injection – Sub-potency

Calcium Gluconate Injection – Particulates

Sodium Chloride Injection -Particulates

Methyldopate HCL Injection – Glass Particles In an injection? Ouch!!!

Sterile Water for Injections – Particulates

Caffeine & Sodium Benzoate Injection – Visible Paticulates

Potassium Phosphates Injection – Translucent Visible Particulates

Ammonium Molybdate Injection – Particulates

Dexamethasone Sodium Phosphate Injection – Particulates


Bacteriostatic Sodium Chloride Injection
– Particulates     This one has more, read on…..

Lot # Expiration Date First Distribution Date
9330 05/2011 06/18/2009
9599 08/2011 10/12/2009
9828 12/2011 03/16/2010

This voluntary recall was initiated because some of the vials of these lots may contain visible particulates. Potential adverse events after intravenous administration of solutions containing particulates
may include
disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness due to accumulation of inflammatory cells), and granuloma formation.
American Regent is undertaking this voluntary recall in consideration of the potential for safety issues if these lots of product are administered to patients.


Potassium Phosphates Injection
– translucent visible particles consistent with glass delamination.

Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation. American Regent is undertaking this recall in consideration of the potential for safety issues if this lot of product is administered to patients.

Potassium Phosphates Injection, USP, 15 mM/5 mL Phosphorus; 22mEq/5 mL Potassium 5 mL Single Dose Vial

NDC # 0517-2305-25 Lot #0048 Exp Date: January, 2012

August 02, 2011 American Regent, Inc. Initiates Voluntary Recall of Seventeen Lots of Vasopressin Injection, USP, Multiple Dose Vials Due to Sub-Potency
July 18, 2011 American Regent Initiates Voluntary Nationwide Recall of Calcium Gluconate Injection, USP, 10%, 100 mL Pharmacy Bulk Package Due to Particulates
June 15, 2011 American Regent Recalls Concentrated Sodium Chloride Injection, USP, 23.4%, 30 mL Single Dose Vial Due to Particulates

June 06, 2011 American Regent Recalls Methyldopate HCL Injection, USP 5 mL Single Dose Vial Due to Glass Particulates
May 19, 2011 American Regent Initiates Nationwide Voluntary Recall of Sterile Water for Injection, USP 50 mL Single Dose Vial Due to Particulate Matter
May 05, 2011 American Regent Recalls Caffeine and Sodium Benzoate Injection, USP 250 mg/mL, 2 mL Single Dose Vial

April 26, 2011 American Regent Initiates Voluntary Nationwide Recall of Ammonium Molybdate Injection, USP (Molybdenum 250mcg/10 mL) 10 mL Single Dose Vial
March 16, 2011 American Regent Initiates Voluntary Nationwide Recall of Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Single Dose Vials;
5 mL and 30 mL Multiple Dose Vials

March 15, 2011 American Regent Recalls Bacteriostatic Sodium Chloride Injection, USP, 0.9% 30 mL Multiple Dose Vials

February 03, 2011 American Regent Recalls Potassium Phosphates Injection, USP 15 mM/5 mL Phosphorus; 22 mEq/5 mL Potassium 5 mL Single Dose Vial, Lot#
0048

2. Mc Neil Consumer 2 recalls:

TYLENOL ® Extra Strength Caplets 225 Count Distributed In
The U.S.

Lot Number ABA619

UPC Code 300450444271

Certain Over-The-Counter (OTC) Products

So where does this leave us?

 

Certain Over the Counter Products??????????? Hmmm take your pick I dug a little

deeper and learned something, if your pills has a musty, moldy smell, don’t use them.

Reason reports of odor – musty, moldy odor linked to presence of trace amounts of a

chemical called 2,4,6, tribromoanisole (TBA). Now the mysterious CERTAIN OVER-THE-

COUNTER (OTC) products are:

Tylenol 8 Hour

Tylenol Arthritis Pain

Tylenol Upper respiratory products

Benadryl

Sudafed PE

Sinutab all distributed in the US, Carribean and Brazil.

These products were manufactured at the McNeil plant in Fort Washington, PA prior to April 2010, when production at the facility was suspended. The company is initiating the recall as a precautionary measure after an extensive review of past production records found instances where equipment cleaning procedures were insufficient or that cleaning was not adequately documented

Rolaids multi-symptom berry tablets sold in the US

Both of these recalls are being initiated at the wholesale level. No action is required by consumers or healthcare providers and consumers can continue to use the product. These actions are not being undertaken on the basis of adverse events.

June 28, 2011

McNeil Consumer Healthcare Announces Voluntary Recall Of One Product Lot Of TYLENOL ® Extra Strength Caplets 225 Count Distributed In The U.S.

January 14, 2011 McNeil Consumer Healthcare Initiates Voluntary Recall Of
Certain Over-The-Counter (OTC) Products

3. Now we have Ortho-McNeil and Risperidone

The recalls stem from two consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole).

Risperidone Tablets

3mg Bottles of 60 Tablets 50458-330-060GG904 May 2012

2mg Bottles of 60 Tablets 50458-593-600LG175 August 2012

June 17, 2011 Ortho-McNeil-Janssen Pharmaceuticals, Inc. Voluntarily Recalls One Lot of RISPERDAL® Tablets and One Lot of Risperidone Tablets

April 14, 2011 Ortho-McNeil Neurologics Voluntarily Recalls Two Lots of TOPAMAX®

4. Qualitest Pharmaceuticals had nationwide recalls for the following products.

Mislabelling with 650 mg pills in 325 mg bottles.

Butalbital, Acetaminophen, and Caffeine Tablets

Qualitest Pharmaceuticals today issued a voluntary nationwide retail level recall of Butalbital, Acetaminophen, and Caffeine Tablets USP, 50mg/325mg/40mg, and Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg/500mg.

This recall was initiated because an individual bottle of Butalbital, Acetaminophen,

and Caffeine Tablets USP, 50mg/325mg/40mg, 500 count was found

incorrectly labeled with a Hydrocodone Bitartrate and Acetaminophen 

Tablets, USP 7.5mg/500mg, 1000 count label, printed with Lot Number

C0590909B. Lots C0390909A, C0400909A, C0410909A used the same stock inventory of labels as Lot C0590909B and are potentially impacted.

Because the recalled bottles may contain incorrect tablets, patients may unintentionally take butalbital and caffeine instead of hydrocodone (Acetaminophen is in both preparations.)

Unintentional administration of butalbital could result in symptoms such as sedation, lightheadedness,

dizziness, and nausea. Additionally, patients with an allergy to butalbital could experience a hypersensitivity

reaction. Side effects due to caffeine are less likely, due to  small amounts in this formulation, however, those individuals with a sensitivity to

caffeine may experience symptoms such as tremors, irritability, and difficulty sleeping. Patients who

were receiving hydrocodone
for chronic pain might experience worsening pain and withdrawal symptoms as aresult of this substitution.
No injuries have been reported to date.

Hydrocodone Bitartrate and Acetaminophen Tablets

An individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count was found incorrectly labeled with a Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count label, printed with Lot Number T150G10B. Lots T120J10E and T023M10A used the same stock inventory of labels as Lot T150G10B and are potentially impacted.

As a result of this mix-up patients may unintentionally take Hydrocodone and acetaminophen tablets, instead of the intended dose of Phenobarbital. Unintentional administration of Hydrocodone can lead to serious adverse events including respiratory depression, CNS depression, coma and death, especially in opioid naïve patients and patients on other CNS depressants. Unintentional administration of acetaminophen may result in liver toxicity in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. Additionally, missing doses of Phenobarbital could result in loss of seizure control.

The recall includes the following products:

  • Butalbital, Acetaminophen, and Caffeine Tablets, USP,
    50mg/325mg/40mg, NDC 0603-2544-28 500 count, Lot Numbers C0390909A, C0400909A, C0410909A, C0590909B
  • Hydrocodone Bitartrate and Acetaminophen Tablets, USP
    7.5mg / 500mg, NDC 0603-3882-32, 1000 count, Lot Numbers C0390909A, C0400909A, C0410909A, C0590909B

June 24, 2011

Qualitest Pharmaceuticals Recalls Four Lots of Butalbital, Acetaminophen, and Caffeine Tablets, USP

50mg/325mg/40mg and Four Lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg/500mg

February 05, 2011

Qualitest Pharmaceuticals Recalls Hydrocodone Bitartrate and Acetaminophen Tablets and Phenobarbital Tablets

And here we have another mislabelling that is with a pretty dangerous combination if

taking a double dose thinking they were taking 325 mg x 2, instead getting 650 mg x 2 =

liver toxicity for the acetaminophen users and the those who consume alcohol.

Endo Pharmaceuticals today issued a voluntary nationwide consumer level recall of Endocet® (oxycodone/acetaminophen, USP) Tablets, 10 mg/325 mg 100 count bottles, NDC 60951-712-70, Lot # 402415NV and #402426NV. One bottle from each lot of Endocet® (oxycodone/acetaminophen, USP) Tablets,  10 mg/325 mg, Lot # 402415NV and # 402426NV, NDC 60951-712-70, 100 count bottles, was found to contain some Endocet® 10 mg/650 mg Tablets, which are identifiable by their larger size, and different shape and markings. Unintentional administration of tablets with increased acetaminophen content may result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. The product label warns consumers that acetaminophen overdosage can potentially cause severe liver damage.

The recall includes the following lots of this product:

  • Endocet® (oxycodone/acetaminophen, USP) Tablets, 10 mg/325 mg 100 count bottles, NDC 60951-712-70, Lot # 402415NV, Expiry 01/2014; and
  • Endocet® (oxycodone/acetaminophen, USP) Tablets, 10 mg/325 mg 100 count bottles, NDC 60951-712-70,Lot # 402426NV, Expiry 01/2014

June 24, 2011 Endo Pharmaceuticals Recalls Two Lots of Endocet (Oxycodone/Acetaminophen, USP) Tablets, 10 MG / 325 MG

June 22, 2011 Nature Relief is Conducting a Voluntary Recall of Nature
Relief Instant Wart and Mole Remover

5. This is a nasty one, imagine being in the hospital and getting Serratia marcescens

bacteremia, a bacterial infection from a catheter.

The Alabama Department of Public Health today is announcing an ongoing investigation of an outbreak of Serratia marcescens bacteremia in six Alabama hospitals. On March 16, ADPH was notified that an outbreak had occurred in two of these hospitals among patients receiving TPN (total parenteral nutrition).

TPN is liquid nutrition fed through an IV using a catheter. Use of contaminated products may lead to bacterial infection of the blood.

March 29, 2011 CDC And ADPH Investigate Outbreak At Alabama Hospitals; Products Recalled

6. Now we have alcohol preps with the Elizabethkingia

meningoseptica from many companies.

The Povidone Iodine Prep Pads are non-sterile and contain some of the same raw material as the recalled Alcohol Prep pads, and were therefore investigated by FDA and by H&P Industries for potential contamination with objectionable organisms. However, analytical testing showed  the presence of objectionable organisms, namely Elizabethkingia meningoseptica. Use of contaminated Povidone Prep Pads

could lead to life-threatening infections, especially in at risk populations, including

neonates, immune suppressed patients, and surgical patients. Treatment options are
limited for Elizabethkingia meningoseptica infections. To date we have not received any reports of adverse
events.
Product List
  • Bronch Procedure Kit
  • Bupivacaine Epidural Bag
  • Cardioplegia Solutions
  • Cefazolin 2 gm Syringe
  • Dialysate Solution
  • Fentanyl /Ropivacaine Epidural Bag
  • Fentanyl/ Bupivacaine Epidural Bag
  • Folic Acid 1mg/0.2ml Syringe
  • Glycopyrrolate 0.2mg/ml 1ml in 3ml Syringe
  • Heparin IV Bags
  • Hydromorphone Intravia Bag
  • Hydromorphone PCA Syringe
  • Ketamine Syringe
  • Labetalol syringe
  • Lorazepam 2mg/ml syr
  • Meperidine 10mg/100ml NS(Intravia Bag)
  • Morphine 1mg/ml PCA 100ml Intravia Bag
  • Neostigmine 3mg Syringe
  • Nitroglycerin IV Bag
  • Nitroglycerin Syringe
  • Norepinehrine IV Bag
  • Oxytocin Bags
  • Sodium Chl 23.4% (4meq/ml) 10ml Syr
  • Succinylcholine 20mg/ml 5ml Syringe
  • TPN Solution
  • Vancomycin IV Bag

June 01, 2011 Aidapak Services, LLC Recalls ALL Repackaged 

Pharmaceuticals by Aidapak Services, LLC Due to Potential Cross Contamination with Beta Lactam Products

May 02, 2011 Bristol-Myers Squibb Recalls Coumadin (Warfarin Sodium) Crystalline 5 mg Tablets, Lot Number 9H49374A

March 29, 2011 CDC And ADPH Investigate Outbreak At Alabama Hospitals; Products Recalled

March 26, 2011 Greenstone Recalls Citalopram and Finasteride Due to Possible Mislabeling

March 25, 2011 APP Pharmaceuticals Issues A Nationwide Voluntary Recall Of Irinotecan Hydrochloride Injection

March 15, 2011 H and P Industries, Inc. Recall of All Lots of Povidine
Iodine Prep Pads


March 05, 2011 OTC DRUG Nationwide Recall–Important information for patients about IV PREP Antiseptic Wipes

February 04, 2011 Watson Announces Important Action Related to Nationwide Recall of Triad Alcohol Prep Products Included in Products

January 24, 2011 Important information for ARIXTRA® Starter Kit patients regarding Triad Group’s alcohol prep products

January 10, 2011 Important Information for Extavia® (interferon beta 1-b) Patients Regarding Triad Group’s Alcohol Prep Products

January 20, 2011 Important Information for Betaseron® (interferon beta 1-b) Consumers Regarding Triad Group’s Alcohol Prep Products

January 05, 2011 Triad Group Issues a Voluntary Nationwide Recall of All Lots of Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks Due to Potential Microbial Contamination

January 26, 2011 Pfizer Inc. And Progenics Alert Physicians And Patients To Information Related To Triad Group Alcohol Prep Products Included In U.S. RELISTOR Kit Packaging

January 13, 2011 Genentech Informs Customers Of Important Information About Triad Groups

And more mislabelled bottles

Upsher-Smith Laboratories, Inc., of Maple Grove, Minnesota is voluntarily expanding its previously announced recall of Jantoven® Warfarin Sodium, USP, 3 mg Tablets to include additional products that were packaged on the same packaging line between May 17, 2010 and November 17, 2010. The company is initiating the recall as a precautionary measure after a bottle labeled as Jantoven® Warfarin Sodium, USP, 3 mg Tablets was found by a retail pharmacy to contain tablets at a higher, 10 mg strength.

Amantadine

Amlodipine


Androxy


Baclofen


Bethanechol


Jantoven®


Oxybutynin

The expanded recall includes the following products:

Product
Batch Number
Expiration Date
Product Identification
Amantadine 100 mg (100-ct bottles)
284166
Aug-12
Peach; imprinted AMT, 832
Amantadine 100 mg (100-ct bottles)
280603
Jul-12
Peach; imprinted AMT, 832
Amantadine 100 mg (100-ct bottles)
283797
Jul-12
Peach; imprinted AMT, 832
Amlodipine 5 mg (90-ct bottles)
280564
May-12
White; scored; imprinted ALP, 5, 832
Amlodipine 5 mg (90-ct bottles)
282661
Aug-12
White; scored; imprinted ALP, 5, 832
Androxy 10 mg (100-ct bottles)
283336
Sep-12
Green; scored; imprinted 86, 832
Baclofen 10 mg (90-ct bottles)
284651
Sep-12
White; scored; imprinted BAC, 10, 832
Baclofen 10 mg (90-ct bottles)
282346
Aug-12
White; scored; imprinted BAC, 10, 832
Baclofen 10 mg (100-ct bottles)
281664
Aug-12
White; scored; imprinted BAC, 10, 832
Bethanechol 5 mg (100-ct bottles)
282255
Aug-12
White; scored; imprinted BCL, 5, 832
Bethanechol 10 mg (100-ct bottles)
280569
Jun-12
White; scored; imprinted BCL, 10, 832
Bethanechol 25 mg (100-ct bottles)
280567
Jun-12
Yellow; scored; imprinted BCL, 25, 832
Jantoven 1 mg (100-ct bottles)
280617
Mar-12
Pink; scored; imprinted WRF, 1, 832
Jantoven 1 mg (100-ct bottles)
282872
Jul-12
Pink; scored; imprinted WRF, 1, 832
Jantoven 2 mg (100-ct bottles)
280598
Jun-12
Lavender; scored; imprinted WRF, 2, 832
Jantoven 2.5 mg (100-ct bottles)
281667
Jul-12
Green; scored; imprinted WRF, 2 ½, 832
Jantoven 3 mg (100-ct bottles)
280612
Jun-12
Tan; scored; imprinted WRF, 3, 832
Jantoven 3 mg (100-ct bottles)
284081
Sep-12
Tan; scored; imprinted WRF, 3, 832
Jantoven 4 mg (100-ct bottles)
283334
Jul-12
Blue; scored; imprinted WRF, 4, 832
Jantoven 5 mg (100-ct bottles)
280581
Jun-12
Peach; scored; imprinted WRF, 5, 832
Jantoven 5 mg (100-ct bottles)
283340
Jul-12
Peach; scored; imprinted WRF, 5, 832
Jantoven 5 mg (100-ct bottles)
283459
Sep-12
Peach; scored; imprinted WRF, 5, 832
Jantoven 5 mg (100-ct bottles)
283455
Jun-12
Peach; scored; imprinted WRF, 5, 832
Jantoven 6 mg (100-ct bottles)
282277
Jun-12
Teal; scored; imprinted WRF, 6, 832
Jantoven 6 mg (100-ct bottles)
284079
Sep-12
Teal; scored; imprinted WRF, 6, 832
Jantoven 7.5 mg (100-ct bottles)
280614
Aug-12
Yellow; scored; imprinted WRF, 7 ½,
 832
Jantoven 10 mg (100-ct bottles)
283342
Aug-12
White; scored; imprinted WRF, 10, 832
Jantoven 10 mg (100-ct bottles)
282917
Feb-12
White; scored; imprinted WRF, 10, 832
Oxybutynin 5 mg (100-ct bottles)
283368
Jul-13
White; scored; imprinted 38, 832

February 18, Upsher-Smith Laboratories Announces Expansion of Voluntary Nationwide Recall. Affected Products Include Amantadine, Amlodipine, Androxy,Baclofen, Bethanechol, Jantoven® and Oxybutynin

February 16, 2011 Upsher-Smith Laboratories Recalls Jantoven® Warfarin
Sodium Tablets, USP, 3mg, Due To Mislabeled Bottles

This product lot is being recalled due to the presence of underweight tablets.

January 06, 2011 Teva Pharmaceuticals, U.S.A issues a voluntary nationwide recall of Metronidazole Tablets USP, 250mg Due to Low Weight Tablets

 

 

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