Drug Recalls | Pharma Watchdog

Cough and cold products recalled

Written by Sadaka Associates
Tuesday, 28 April 2009 10:35
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FOR IMMEDIATE RELEASE — Clearwater, Fl. – April 13, 2009 — ION Labs Inc. of Clearwater, FL. is voluntarily recalling all of the Influend Cough and Cold products sold on or after May 30, 2008. ION Labs Inc. is Recalling the listed products due to the products not tested in conformance with the specifications of the lab, therefore the products may have a possibility to be super potent. Possible complications may include Tachycardia, palpitations, arrhythmias, cardiovascular collapse with hypotension, headaches, dizziness, anxiety, restlessness and nervousness. The following products were distributed and sold directly to consumers in the Madison/Huntsville, Alabama area:

* Influend Cold and Cough, 24 Tablets, Product Code/ Lot # 800074
* Influend Severe Cold & Flu, 24 Tablets, Product Code/Lot# 800075
* Influend JR. Cold & Cough, 4 oz. bottle, Product Code/Lot# 800076
* Influend JR. Severe Cold & Flu, 4 oz. bottle, Product Code/Lot# 800077

While no illnesses have been reported to date, ION Labs, Inc. has ceased distribution of these products until further notice.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product. Please return the product for a full refund to the address below.

ION Labs, Inc.
115th Ave. N.
Clearwater, Fl. 33760

Any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at the MedWatch website at www.fda.gov/medwatch

Consumers who have questions about the above recall may contact ION Labs Customer Service at 1-877-990-4466 and ask for the Quality Director at Ext. (212). Hours of operation are M-F from 8 a.m. to 5 p.m. EDT.

More Digoxin tablets recalled

Written by Sadaka Associates
Thursday, 02 April 2009 08:31
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Poor Quality Control Leads to Varying Amount of Active Ingredient

Caraco Pharmaceutical Laboratories and FDA notified healthcare professionals of a consumer-level recall of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin, a drug product used to treat heart failure and abnormal heart rhythms.

Increased Risk of Digoxin Toxicity

The drug has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability. Consumers with the recalled product should return these products to their pharmacy or place of purchase.

Generic drug manufacturer KV Pharmaceutical Company expands recall

Written by Sadaka Associates
Wednesday, 04 February 2009 10:00
No Comments

ETHEX Corporation, a subsidiary of KV Pharmaceutical Company (NYSE: KVa; KVb), is issuing a voluntary expansion to the retail level of a previously announced recall on certain products. The recall on the products listed below had previously been issued to the wholesale level, but is now being expanded to the retail level. The Company is taking this action as a precautionary measure, because the products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practice (cGMP). This additional level of recall is to further remove recalled products from the marketplace.

Patients who may have these products in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medications may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products. Lawyers for the company could not be reached for comment.

Expanded Recall to Retail Level Includes the Following Products:

Morphine Sulfate Extended-Release Tablets 15mg, 30mg & 60mg (All Strengths)

Morphine Sulfate Immediate-Release Tablets 15mg & 30 mg (All Strengths)

Dextroamphetamine Sulfate Tablets 5mg & 10mg (All Strengths)

Isosorbide Mononitrate Extended-Release Tablets 30mg, 60mg & 120mg (All Strengths)

Propafenone HCl Tablets 150mg, 225mg & 300 mg (All Strengths)

Any retail customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-748-1472, faxed to ETHEX Customer Service at 314-646-3788, or e-mailed to customer-service@ethex.com. Representatives are available Monday through Friday, 8 am to 5 pm CST.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). At this time, the Company is unable to determine when distribution of these products will resume.

Patients with questions about the recall should call the telephone number above, or contact their healthcare providers. Any adverse reactions experienced with the use of these products should also be reported to FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

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Poor Quality Control Leads to Varying Amount of Active Ingredient

Increased Risk of Digoxin Toxicity