Warfarin - Jantoven - Recall

[Freddie]

Warfarin Sodium Tablets (Jantoven), 3mg: Recall - Mislabeled Bottles Containing Higher Dosage
AUDIENCE: Pharmacy, Family Practice, Consumer

ISSUE: Upsher-Smith Laboratories and FDA notified healthcare professionals of the recall of one lot of Jantoven Warfarin Sodium, USP, 3mg Tablets, an anticoagulant, after a single bottle labeled as Jantoven Warfarin Sodium, USP, 3mg Tablets was found to contain tablets at a higher 10mg strength. To date, the company has identified no additional mislabeled bottles.

BACKGROUND: The recalled lot is numbered as #284081, with an expiration date of September 2012. The product lot was distributed to wholesalers, retail chains and independent pharmacies throughout the United States. The primary risk of substituting 10mg warfarin for 3mg warfarin is overdosing more than 3 times the labeled amount which leads to excessive anticoagulation that could be expected to result in life-threatening hemorrhage in patients.

RECOMMENDATION: The two Jantoven tablets (see photo at link below) can be readily identified by color: the 3mg tablet is tan and the 10mg tablet is white. In addition, the 3mg tablet is imprinted with the letters WRF, a line, and the number 3 below the line. The reverse side of the 3mg tablet carries the number 832. The 10mg tablet is imprinted with the letters WRF, a line, and the number 10 below the line. The reverse side of the 10mg tablet carries the number 832. Consumers and pharmacists can call the Upsher-Smith medical information line at 1-888-650-3789 for more information and to access product details, Monday-Friday between 8:00 a.m. and 5:00 p.m. (CST).


Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including links to the company press release and product photos, at:

http://www.fda.gov/Safety/MedWatch/S.../ucm243850.htm

 

[Greg a]

I smell lawsuits

 

[dick0236]

I smell lawsuits

ya think:redface2:

 

[Protimenow]

If this (these?) mislabeled bottles were caught and recalled quickly enough, there may be little cause for lawsuits. Of course, the FDA will probably want to find out how this happened, and may fine the manufacturer. For any regular users of warfarin, it may not be expecting TOO much that they realize these pills LOOK different from what they normally take.

 

[Lynlw]

UPDATE

http://www.fda.gov/Safety/Recalls/ucm244111.htm
(I can't get the chart to show up easy to read, so you can go to the link for a better chart of the meds recalled)

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.



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


Contact:
Elizabeth Likly
Kovak-Likly Communications
203-762-8833
[email protected]



FOR IMMEDIATE RELEASE - February 18, 2011 - 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.

At Upsher-Smith, patient safety is of foremost concern. The substitution of warfarin, or any other product, may lead to a change in the therapeutic effect of the intended drug.

Consistent, continuous dosing of any product is necessary for optimal care for many ill patients. Patients should check with their health care provider regarding the appropriateness of their current therapy prior to making any change.

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 (90-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

Upsher-Smith Laboratories is working cooperatively with the U.S. Food and Drug Administration to implement a nationwide recall as quickly and efficiently as possible.

The products affected were distributed to wholesalers, retail chains and independent pharmacies throughout the United States. The company is notifying its pharmacy customers and wholesalers, and arranging for the return of all recalled products. These products were packaged at the Upsher-Smith plant in Plymouth, Minnesota.

Consumers and pharmacists can call 1-877-492-4791 for more information and to access product details, Monday-Friday between 8:00 a.m. and 5:00 p.m. (EST).

Any adverse reactions may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: http://www.fda.gov/medwatch/report.htm1
Regular Mail: Use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm2. Mail to address on the pre-addressed form.
Fax: 1-800-FDA-0178