Diabetes Related Recalls

[We Hope]

Abbott FreeStyle Strips Recall

http://www.fda.gov/bbs/topics/ENFORC.../ENF01073.html

PRODUCT

Abbott Free Style Blood Glucose Monitoring System Test Strips for use with FreeStyle Blood Glucose Monitoring Meter, Recall # Z-1813-2008

CODE

Part numbers/Serial numbers/Exp. Date: CAT12050-01/0618625/Jul08; M70449-03/0703325/Feb09; CAT12450-01 (70345-02)/0618129/Jun08; CAT70450-01/0700815/Jan09; CAT70447-02/0628646/Oct08; CAT12450-01 (70345-02)/0627030/Sep08; CAT70450-02/0703019/Jan09; CAT12050-02/0703118/Jan09; CAT12050-03/0715129/May09

RECALLING FIRM/MANUFACTURER

Abbott Diabetes Care, Inc., Alameda, CA, by letters, visits or telephone on April 24, 2008. Firm initiated recall is ongoing.

REASON

Flaws in strip voltage continuity may result in frequency of an Error 3 (“Er3”) message display and unreadable strips. This issue has the potential for creating a delay in generating blood glucose results and to delay diabetes management, potentially leading to either hypo or hyperglycemia and their associated complications.

VOLUME OF PRODUCT IN COMMERCE

2,954,900 strips

DISTRIBUTION

Nationwide and Internationally

[We Hope]

Re: ReliOn insulin syringe recall

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01911.html

FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes
The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death.

The recall applies to the following lot number and product information:

-- Lot Number 813900
-- ReliOn 1cc, 31-gauge, 100 units for use with U-100 insulin

Only ReliOn syringes from this lot number and labeled as 100 units for use with U-100 insulin are the subject of the recall.

These syringes are distributed by Can-Am Care Corp and sold only by Wal-Mart at Wal-Mart stores and Sam's Clubs under the ReliOn name. Wal-Mart requests that all users of ReliOn 31-gauge, 1cc syringes return those labeled as 100 units for use with U-100 insulin from Lot Number 813900 to their local Wal-Mart store or Sam's Club pharmacy. Customers will be provided with replacement product.

The FDA urges patients and health care professionals to check their syringe packaging carefully for syringes labeled as 100 units for use with U-100 insulin from Lot Number 813900.

Consumers and health care professionals who suspect they have the recalled product may also contact Covidien at 866-780-5436 or www.relion.com/recall for more information.

ReliOn Insulin Syringes consist of a syringe barrel, a plunger rod, and a hypodermic needle attached to the tip of the syringe.

During the packaging process for this lot, some syringes labeled for use with U-40 insulin were mixed with syringes labeled for use with U-100 insulin, then all packaged individually and in boxes as 100 units for use with U-100 insulin.

The manufacturer has distributed 4,710 boxes in the recalled lot, which equals 471,000 individual syringes. Wal-Mart sold the syringes at Wal-Mart stores and Sam's Clubs from Aug. 1, 2008, until Oct. 8, 2008.

Tyco Healthcare Group LP (Covidien) voluntarily recalled this lot of syringes on Oct. 9, 2008, asking that any units of the affected product be removed from inventory and placed in quarantine. Wal-Mart posted the recall announcement in Wal-Mart stores and Sam's Clubs, as well as on its Web site, and sent letters to more than 16,500 customers notifying them of the recall.

The manufacturer has received one adverse report related to a syringe from this product lot. Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

[k9diabetes]

OneTouch Ultra Strips recalled

From Louise at the Cushings Board (www.caninecushings.net)

I received a letter from LifeScan today (dated Sept. 19 by the way) regarding a recall of the One Touich Ultra Test Strips 25-count. I am a user of this product and I immediately thought of the doggies with diabetes who are being tested with these strips. I looked over at the FDA website and there was no recall notice yet.

Here's the pertinent information:

This letter is to let you know that LifeScan is voluntarily removing and offering to replace 25-count One Touch Ultra Blood Glucose Test Strips with a lot number on the package of 2829235. We are replacing them because we have learned that a very small number of vials in this lot may contain strips that could produce inaccurately low blood glucose test results.

We have also informed the U.S. Food and Drug Administration of this action.

Please note that this concern only applies to a very limited quantity of the 25-count packages.

If you only use 50 or 100 count packages of One Touch Ultra Test Strips, or if your 25-count test strips do not have a lot number of 2829235, please note that your test strips are not affected by this issue and that you can continue to use them with confidence to test your blood glucose.

If you do have One Touch Ultra Test Strips from Lot number 2829235, please discontinue their use and call LifeScan at 1 (866) 247-1281 to receive replacement test strips.

[We Hope]

Re: OneTouch Ultra Strips recalled

This is important as there's nothing at FDA but we now have the link about the strips from LifeScan, makers of OneTouch Ultra:

http://www.lifescan.com/company/abou...tstrips092008/

Letter to OneTouch® Ultra® Test Strip Customers
--Urgent Medical Device Recall: OneTouch Ultra Test Strips- 25-count from Lot #2829235 Only--

September 19, 2008

At LifeScan, we hold our products to the highest standards of quality; constantly working to ensure they provide glucose results you can rely on. For that reason, we're also committed to communicating with you when we learn of product that may not be performing to our expected standards.

If you use OneTouch® Ultra® Test Strips to test your blood glucose, have patients who use them, or distribute or sell OneTouch Ultra Test Strips, please be aware that LifeScan is voluntarily removing and offering to replace 25-count OneTouch Ultra Blood Glucose Test Strips with a lot number on the package of 2829235. We are replacing them because we have learned that a very small number of vials in this lot--sold only in the United States--may contain strips that could produce inaccurately low blood glucose test results.

Please note that this concern only applies to a very limited quantity of the 25-count packages sold in the United States from Lot 2829235.

If you only use 50- or 100-count packages of OneTouch Ultra Test Strips or if your 25-count test strips do not have a lot number of 2829235, your test strips are not affected by this issue and you can continue to use them with confidence to test your blood glucose.

How to Tell If Your OneTouch Ultra Test Strips Are Affected

Please check the lot numbers of any 25-count OneTouch Ultra Test Strips in your possession. The lot number appears on the outside of the test strip box and on the label of the test strip vial.

If you do not have any product from OneTouch Ultra Test Strip Lot 2829235, then your test strips are not subject to this recall and no further action is required. You can continue to use your test strips to test your blood glucose.

Do Not Use OneTouch Ultra Test Strips from Lot 2829235 - Call LifeScan

If you do have OneTouch Ultra Test Strips from Lot number 2829235, please discontinue their use and call LifeScan to tell the customer service representative that you have test strips that need to be replaced. You should also tell the representative if you have other test strips available to test with while you wait for replacement strips. The LifeScan representative will provide information on how you can return your test strips from Lot 2829235 and will make arrangements for any replacement test strips.

Please know that LifeScan takes this issue very seriously. We continually strive to ensure that we provide you with product of the highest quality. In addition, we have informed the U.S. Food and Drug Administration of this situation and the steps we have taken to resolve it.

We apologize for any inconvenience this issue may cause. Thank you for your continued support of LifeScan.

How to Contact LifeScan

People with diabetes
Telephone: 866 693-0602
Health Care Professionals
Telephone: 866 693-0598

Retailers/Distributors
Telephone: 866 693-0597



Kathy

[We Hope]

Re: Important Recalls and Warnings - Food, Meds, Etc.

http://www.fda.gov/bbs/topics/ENFORC.../ENF01083.html

FDA Enforcement Report November 26, 2008

PRODUCT

One Touch Ultra Test Strips, part number 020-994-02, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use 0outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm, Recall # Z-0004-2009

CODE

Lot number: 2829235

RECALLING FIRM/MANUFACTURER

Lifescan Inc., Milpitas, CA, by letters, dated September 19, 2008. Firm initiated recall is ongoing.

REASON

Products exceed inaccuracy threshold, with many complaints resulting from inaccurate low results.

VOLUME OF PRODUCT IN COMMERCE

35,308 vials

DISTRIBUTION

Nationwide and PR

[We Hope]

Warning--Stolen Levemir--FDA

http://www.fda.gov/NewsEvents/Newsro.../ucm166358.htm

For Immediate Release: June 13, 2009

FDA Issues Public Health Advisory Regarding Levemir Insulin

http://press.novonordisk-us.com/index.php?s=43&item=204

Novo Press Release

PRINCETON, N.J., June 13 /PRNewswire-FirstCall/ -- Novo Nordisk product previously reported as stolen in North Carolina has resurfaced recently at a medical center in Houston.


Three lots of 10 ml vials of insulin, marketed under the brand name Levemir® (insulin detemir [rDNA origin] injection), were taken in the original theft and identifiable by the following lot numbers: XZF0036, XZF0037, XZF0038.


A vial or vials of stolen insulin from lot XZF0037 was discovered this week at a medical center in the Houston area. Insulin from these lots did not circulate through the normal Novo Nordisk distribution channel and therefore proper storage conditions for the insulin may not have been followed.


Patients can locate the lot number on the side of the box of insulin or the side of the vial. If a patient finds their insulin is from one of the stolen lots, they should not use the insulin and contact Novo Nordisk Customer Care Center at 1-800-727-6500 for further information and instructions.


Kathy

Note--something on the copy of the FDA notice about the stolen Levemir insulin has triggered a white list/internal server error which will not allow me to post it.

[We Hope]

Diabetes Related Recalls

http://www.fda.gov/downloads/Safety/.../UCM167873.pdf

FDA Enforcement Report June 17, 2009 Page 345

NIPRO Disposable Insulin Syringe 1cc 29G X 1/2", U-40 Insulin, Single Use, Reorder No. JD+01U2913-40, Vetierinary Use Only, Not For Human Use, Latex Free, Packaging is 1 case/30 boxes/10 pouches/10 syringes (resulting in 3000 pieces per case). UPC 383791940015 (pouch), 383791940107 (box), 3383791940315 (case). Recall #V-209-2009.

CODE
Lot No. 20071026; Expiration Date 20101025 (October 25, 2010)

RECALLING FIRM
Nipro Medical Corporation, Miami, FL, by telephone, email and letter on May 22, 2009
MANUFACTURER Nipro Corporation, Osaka, Japan. Firm initiated recall is ongoing.

REASON
Insulin syringes, for animal use, size 0.05 cc were packed into pouches, boxes and cases labeled as 1.0 cc, which could result in incorrect dose of insulin.

VOLUME OF PRODUCT IN COMMERCE
87 cases/30 boxes/10 pouches of 10 syringes each (261,000 units)

DISTRIBUTION
OHIO

[We Hope]

Diabetes Related Recalls

http://www.fda.gov/Safety/Recalls/En.../ucm170185.htm

US-FDA Enforcement Report July 1, 2009

PRODUCT

AccuSure, U-100 31 Gauge, Icc Insulin Syringe, 5/16” (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7002-2. Recall # Z-1504-2009

CODE

Lot A07001, exp 07/2012

RECALLING FIRM/MANUFACTURER

Recalling Firm: Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals, Huntsville, AL, by press release and letter on April 9, 2009.

Manufacturer: Feel Tech, Chungnam, Republic of South Korea. Firm initiated recall is ongoing.

REASON

Needles separate from the barrel of the syringe.

VOLUME OF PRODUCT IN COMMERCE

559,500 syringes

DISTRIBUTION

Nationwide

[We Hope]

Diabetes Related Recalls

http://www.fda.gov/Safety/Recalls/ucm179943.htm

Qualitest Pharmaceuticals, Inc.Issues a Voluntary Nationwide Recall of
Accusure® Insulin Syringes (1/2 Cc – 31 G – Short Needle) Lot #6jcb1 and Accusure® Insulin Syringes (1 Cc – 31 G – Short Needle) Lot #7cpt1

FOR IMMEDIATE RELEASE -- August 21, 2009 -- Huntsville, AL - Qualitest Pharmaceuticals, Inc., today has issued a voluntary nationwide recall of Accusure® Insulin Syringes (1/2 cc – 31 G – Short Needle) with lot number 6JCB1 (Expiration 10/2011) – NDC 0603-7001-21. This lot was distributed between January 2007 and June 2007 to wholesalers and retail pharmacies nationwide (including Puerto Rico). Also today, Qualitest has issued a voluntary nationwide recall of Accusure® Insulin Syringes (1 cc – 31 G –Short Needle) with lot number 7CPT1 (Expiration 03/2012) – NDC 0603-7002-21 This lot was distributed between May 2007 and June 2008 to wholesalers and retail pharmacies nationwide (including Puerto Rico). The syringes in these lots have been found to have needles which can detach from the syringe.

When the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after an injection.

Consumers who have any Accusure® Insulin Syringes (1/2 cc – 31 G –Short Needle) with lot number 6JCB1 or Accusure® Insulin Syringes (1 cc – 31 G –Short Needle) with lot number 7CPT1 should stop using them and contact Qualitest at 1-800-444-4011 for product replacement instructions. You can find the lot number on the white paper backing of each individual syringe.

Qualitest is notifying all customers who received the product and arranging for return of any affected product.

Consumers with questions may contact Qualitest at 1-800-444-4011 for more information.

This is for:

Accusure® Insulin Syringes (1/2 cc – 31 G – Short Needle) with lot number 6JCB1 (Expiration 10/2011) – NDC 0603-7001-21

Accusure® Insulin Syringes (1 cc – 31 G –Short Needle) with lot number 7CPT1 (Expiration 03/2012) – NDC 0603-7002-21

As you see here, this is the second recent recall for this brand of insulin syringes.

[We Hope]

Re: Warning--Stolen Levemir--FDA

http://www.fda.gov/NewsEvents/Newsro.../ucm180239.htm

FDA Warns About Stolen Insulin
Update to June Alert

The U.S. Food and Drug Administration is reminding the public that stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. still may be on the market.

Evidence gathered to date suggests that the stolen insulin was not stored and handled properly and may be dangerous for people to use. The FDA has received multiple reports of patients who suffered an adverse event due to poor control of glucose levels after using a vial from one of the stolen lots.

When the FDA first alerted the public to the theft in June, it reported that three lots of Levemir totaling 129,000 vials had been stolen in North Carolina. So far only about 2 percent of the total amount stolen has been recovered.

The FDA continues to aggressively investigate this matter and is asking for the public's help in reporting any information regarding these vials to the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site.

The agency is advising patients who use Levemir insulin to:

1. Check your personal supply of insulin to determine if you have Levemir insulin from one of the following lots: XZF0036; XZF0037; XZF0038. You can locate the lot number on the side of the box of insulin and also on the side of the vial.

2. Do not use your Levemir insulin if it is from one of these lots. Replace it with a vial of Levemir insulin from another lot. If you must switch to another brand of insulin for any reason, first contact your health care provider because another insulin product may require adjustments in dosing.

3. Always look at your insulin carefully before using it. Levemir is a clear and colorless solution.

Updating this story, as much of the improperly kept stolen Levemir still may be available on the market.

[We Hope]

Re: Accusure (Qualitest) Insulin Syringe Recall

This rolling recall has been extended to cover ALL insulin syringes by Qualitest:

http://www.fda.gov/Safety/Recalls/ucm188137.htm

Qualitest Pharmaceuticals Issues a Voluntary Nationwide Recall of All Accusure® Insulin Syringes

FOR IMMEDIATE RELEASE - October 27, 2009 - Huntsville AL-Qualitest Pharmaceuticals today issued a voluntary nationwide recall of all Accusure® Insulin Syringes. The distributed syringes are of the following descriptions and NDC numbers:

28G 1/2cc, NDC 0603-6995-21;
28G 1cc, NDC 0603-6996-21;
29G 1/2cc NDC 0603-6997-21,
29G 1cc, NDC 0603-6998-21,
30G 1/2cc, NDC 0603-999-21,
30G 1cc, NDC 0603-7000-21,
31G 1/2cc, NDC 0603-7001-21;
31G 1cc, NDC 0603-7002-21.

All Accusure® Insulin Syringes regardless of lot number are subject to this recall. These syringes were distributed between January 2002 and October 2009 to wholesale and retail pharmacies nationwide (including Puerto Rico). The syringes in these lots may have needles which detach from the syringe.

If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection.

Consumers who have any Accusure® Insulin Syringes should stop using them and contact Qualitest at 1-800-444-4011 for reimbursement. You can find the lot number on the white paper backing of each individual syringe.

Qualitest is notifying all customers who received these syringes and arranging for the return of any affected product.

The recall is being made with the knowledge of the Food and Drug Administration.

Consumers with questions may contact Qualitest at 1-800-444-4011 for more information.

Adverse reactions or quality problems experienced with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either on line, by regular mail or by fax.