View Full Version : Barr recall of Dextroamphetamine/Amphetamine 20mg Tablets


blueroo
08-15-09, 05:39 PM
Moderators, please sticky. A cross-post in the general forum might be useful as well.

http://www.fda.gov/Safety/Recalls/ucm177321.htm

Barr Laboratories, Inc. issues a voluntary nationwide recall of Dextroamphetamine/Amphetamine 20mg Tablets, Lot number 311756

Contact:
Denise Bradley
215-591-8974

FOR IMMEDIATE RELEASE - August 13, 2009 - Barr Laboratories, Inc. is initiating a voluntary recall of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of a Single Entity Amphetamine Product) 20mg Tablets, 100 count bottles, lot number 311756. The product identified is being recalled because the affected lot may contain some tablets exceeding weight requirements which may lead to super-potent tablets.

Potentially clinically significant adverse reactions to a supratherapeutic dose could include cardiovascular, neurologic, psychiatric and gastrointestinal reactions such as: palpitations, tachycardia, hypertension, headache, tremor, tic, dyskinesia, dizziness, blurred vision, sweating, insomnia, agitation, euphoria, mania, anxiety, restlessness, nausea, diarrhea, constipation, dry mouth, and decreased appetite.

This product can be uniquely identified as an oval peach colored tablet, debossed with b/973 on one side and 2/0 on the other side. Barr distributed the affected lot between 06/11/09 and 06/16/09. Only lot 311756 is affected by this recall.

Customers who have this lot in their possession are instructed to cease using the product and return it to their pharmacy/distributor. Wholesalers and retailers should cease distribution and examine their inventory immediately.

Consumers with questions may contact 888-742-5578 from 8:00am - 8:00pm EDT Monday-Friday.

Barr Laboratories has not received any adverse events for this product lot.

The FDA has been apprised of this action.

Any adverse reactions experienced with the use of this product should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; by mail at MedWatch, HF-410, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at http://www.fda.gov/Safety/MedWatch/default.htm.

sauer_kraut
08-16-09, 09:47 AM
Sooo how are we supposed to know what lot # we have?

PedroDaGr8
08-16-09, 03:03 PM
Contact your pharmacist. They should have the records.

5speedz34
08-19-09, 10:16 PM
I'm a pharmacy technician at a local CVS. I just saw the Class 1 recall today. My pharmacist was contacting the people we dispensed these too and was refilling with a different brand or a new lot number.

Our system automatically prints a list of who's received these meds.

charlottesw
08-20-09, 04:46 AM
I just got a script of this type of adderall filled on the 16th. These 20 mg tablets I have been taking two times a day, (40mg), and Dr just upped the dose to 60 mg

The difference is remarkably clear in this increase more than all the others. I am 5 3 and 118 lbs, I am wondering if i have been taking the recalled lot after reading this because i have gotten four hours of sleep since the increase. I need sleep, my body is exhausted but my mind will not let me rest.

this has never happened to me before. I started taking adderall in early april when I was diagnosed with ADHD and found it so helpful, and the past two days have felt almost hellish. When I first take my dose and it kicks in I feel hyper focused, and by about 5 oclock at night I am so irritable and my stomach hurts like theres a pit in it. Every time i close my eyes my thoughts race, which happened to me often before i knew i suffered adhd. I found the adderall relieved this, but now i just feel like i had 20 cups of coffee, my heart races, and I will be laying in the dark and my eyes pop open as if someone was shining a light in them!

I think that i may be taking the recalled batch, and i am absolutely terrified. somebody please respond soon with advice or experience, or maybe it is just that 60 is too high??? i have no idea but im scared and i need sleep

UAMA2000
08-20-09, 11:37 AM
I just got a script of this type of adderall filled on the 16th. These 20 mg tablets I have been taking two times a day, (40mg), and Dr just upped the dose to 60 mg

The difference is remarkably clear in this increase more than all the others. I am 5 3 and 118 lbs, I am wondering if i have been taking the recalled lot after reading this because i have gotten four hours of sleep since the increase. I need sleep, my body is exhausted but my mind will not let me rest.

this has never happened to me before. I started taking adderall in early april when I was diagnosed with ADHD and found it so helpful, and the past two days have felt almost hellish. When I first take my dose and it kicks in I feel hyper focused, and by about 5 oclock at night I am so irritable and my stomach hurts like theres a pit in it. Every time i close my eyes my thoughts race, which happened to me often before i knew i suffered adhd. I found the adderall relieved this, but now i just feel like i had 20 cups of coffee, my heart races, and I will be laying in the dark and my eyes pop open as if someone was shining a light in them!

I think that i may be taking the recalled batch, and i am absolutely terrified. somebody please respond soon with advice or experience, or maybe it is just that 60 is too high??? i have no idea but im scared and i need sleep

Relax, you should go back down to 40/day. 60 is probably too much for your weight. Moreover, 60 is usually the max daily dosage as per the FDA. Someone of your size is probably better off with the 40. You probably shouldn't take your last dosage beyond 5pm or so either; that way, you'll be all set to crash whenever it is that you go to sleep at night.

jmickel1234
08-20-09, 02:27 PM
I have been taking 20mg tablets of barr brand adderall for over 2 years. Just recently I have been experiencing all of the overdose side affects. I have a heart condition as well as a pacemaker. I just went through a nervous breakdown a week ago and no I'm having severe stomach aches, loss of appetite, sores all over me. I was just diagnosed with follicalitis yesterday. I have been to my phyciatrist several times and placed on a high dose of valium for my mental state. Please help!!!!!!! I've had to contact my cardiologist due to the negative cardiovascular side affects. I strongly believe I did receive the bad batch of this medication. My life has taken a very dramatic change all associated with the bad side affects of an adderall overdose. Moderators, please sticky. A cross-post in the general forum might be useful as well.

http://www.fda.gov/Safety/Recalls/ucm177321.htm

Barr Laboratories, Inc. issues a voluntary nationwide recall of Dextroamphetamine/Amphetamine 20mg Tablets, Lot number 311756

Contact:
Denise Bradley
215-591-8974

FOR IMMEDIATE RELEASE - August 13, 2009 - Barr Laboratories, Inc. is initiating a voluntary recall of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of a Single Entity Amphetamine Product) 20mg Tablets, 100 count bottles, lot number 311756. The product identified is being recalled because the affected lot may contain some tablets exceeding weight requirements which may lead to super-potent tablets.

Potentially clinically significant adverse reactions to a supratherapeutic dose could include cardiovascular, neurologic, psychiatric and gastrointestinal reactions such as: palpitations, tachycardia, hypertension, headache, tremor, tic, dyskinesia, dizziness, blurred vision, sweating, insomnia, agitation, euphoria, mania, anxiety, restlessness, nausea, diarrhea, constipation, dry mouth, and decreased appetite.

This product can be uniquely identified as an oval peach colored tablet, debossed with b/973 on one side and 2/0 on the other side. Barr distributed the affected lot between 06/11/09 and 06/16/09. Only lot 311756 is affected by this recall.

Customers who have this lot in their possession are instructed to cease using the product and return it to their pharmacy/distributor. Wholesalers and retailers should cease distribution and examine their inventory immediately.

Consumers with questions may contact 888-742-5578 from 8:00am - 8:00pm EDT Monday-Friday.

Barr Laboratories has not received any adverse events for this product lot.

The FDA has been apprised of this action.

Any adverse reactions experienced with the use of this product should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; by mail at MedWatch, HF-410, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at http://www.fda.gov/Safety/MedWatch/default.htm.

UAMA2000
08-21-09, 10:22 AM
http://www.attorneyatlaw.com/2009/08/barr-labs-tablets-recalled-may-be-oversized-and-potentially-dangerous-fda-says/

specialk4959
08-21-09, 10:55 PM
I have been taking generic adderall on and off for the last several years. Most recently after a couple years off I started up again around a year ago. I have been using the generic formula made by Barr labs now Teva. From what I've gathered it appears Teva has changed the generic formula Barr had been using but I may be wrong.

I filled my last prescription in the beginning of July and recently found out I had been given the recalled batch which I had been taking at 40mg IR per day for the last month. Since then I have been experiencing heart palpitations and muscle tics in my chest and other areas of my body. I am now stopping my adderall use for the weekend to see how my body responds. If I do go back on adderall next week I will no longer be using Teva brand generics and have already called my pharmacy to ensure they have placed a note on my account to only fill my prescriptions with Eon lab or now Sandoz brand generics. I would advise anyone whether affected by the recall or not to proceed cautiously if using Teva brand adderall.

twinch42085
08-22-09, 02:32 AM
Is this recall before or after the new formulation for Adderall IR ???

charlottesw
08-22-09, 06:30 PM
JUST GOT A LETTER IN THE MAIL FROM THE PHARMACY

my adderall was recalled.

grrrreeeaaaaaattttt :D

blueroo
08-24-09, 02:49 AM
I have been taking 20mg tablets of barr brand adderall for over 2 years. Just recently I have been experiencing all of the overdose side affects. I have a heart condition as well as a pacemaker. I just went through a nervous breakdown a week ago and no I'm having severe stomach aches, loss of appetite, sores all over me. I was just diagnosed with follicalitis yesterday. I have been to my phyciatrist several times and placed on a high dose of valium for my mental state. Please help!!!!!!! I've had to contact my cardiologist due to the negative cardiovascular side affects. I strongly believe I did receive the bad batch of this medication. My life has taken a very dramatic change all associated with the bad side affects of an adderall overdose.

Call your pharmacist as soon as possible and make them look up the batch that your medicine came from. They can tell you if your adderall is from the bad batch.