[Posted 04/21/2017] AUDIENCE: Pharmacy, Patient ISSUE: C.O. Truxton, Inc. is voluntarily recalling lot 70952A of Phenobarbital Tablets, USP, 15 mg, to the consumer/user level. The manufacturer received a confirmed customer complaint that a bottle labeled as phenobarbital 15 mg was found to contain phenobarbital 30 mg tablets. This mislabeled product…
H-E-B Voluntarily Issues a Precautionary Recall H-E-B and Hill Country Fare sandwich bread with a best buy date of April 29th or earlier being recalled for potential rubber in the product
H-E-B, committed to the quality of its products, is voluntarily issuing a precautionary recall for H-E-B and Hill Country Fare sandwich bread with a best by date of April 29 or earlier due to the possible presence of a single piece of rubber in the product. This was an isolated incident. Bread purchased in the…
C.O. Truxton, Inc. Issues Voluntary Nationwide Recall of Phenobarbital 15 mg Tablets, USP due to Labeling Error on Declared Strength
Bellmawr, New Jersey, C.O. Truxton, Inc. is voluntarily recalling lot 70952A of Phenobarbital Tablets, USP, 15 mg, to the consumer/user level. The manufacturer received a confirmed customer complaint that a bottle labeled as phenobarbital 15 mg was found to contain phenobarbital 30 mg tablets. This mislabeled product could expose the consumer or their pet(s) to…
FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women
CodeineA search of the FDA Adverse Event Reporting System (FAERS) database from January 1969 to May 2015 identified 64 worldwide cases of respiratory depression, including 24 deaths, with codeine-containing medicines in children younger than 18 years. Fifty cases were reported in children younger than 12 years. Respiratory depression occurred after the children received a range…
Codeine and Tramadol Medicines: Drug Safety Communication – Restricting Use in Children, Recommending Against Use in Breastfeeding Women
[Posted 04/20/2017] AUDIENCE: Pediatrics, OB/GYN, Internal Medicine ISSUE: FDA is restricting the use of codeine and tramadol medicines in children. These medicines carry serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used…
Codeine and Tramadol Can Cause Breathing Problems for Children
En Español Get Consumer Updates by email. Codeine and tramadol are opioid medicines that may be used to treat pain. Codeine is also in some cough and cold remedies. These medicines can cause life-threatening breathing problems in children. Some children and adults break down codeine and tramadol into their active…
April 12, 2017: Former Medical Product Distributor Charged with False Statements about Hormone Shipments
Food and Drug Administration Office of Criminal Investigations BIRMINGHAM – Federal prosecutors on Tuesday charged a former Homewood medical product distributor for falsely stating to a U.S. postal inspector that packages of human pregnancy hormone shipped to him from China contained cosmetics he ordered as a gift…
Problems with E-Cigarettes, Vape Products, Hookah, Cigarettes or Other Tobacco Products? Tell the FDA
Get Consumer Updates by email. En Español Have you used a tobacco product—an e-cig, cigar or cigarette, hookah or smokeless tobacco—that you believe is defective or is causing an unexpected health problem? Does the product have a strange taste or smell, has your vape battery exploded, or is there some…
Organic Herbal Supply Supplement Products: Recall – Undeclared Drug Ingredients
Including Uproar, Cummor, Zrect, LabidaMAX, Monkey Business, Xrect, Rectalis, Tornado, Zdaily, BigNHard, Enhancerol Natural Male Enhancement capsules [Posted 04/19/2017] AUDIENCE: Consumer ISSUE: Organic Herbal Supply, Inc. announced that it is conducting a voluntary nationwide recall of all lots of Uproar, Cummor, Zrect, Monkey Business, Xrect, Rectalis, Tornado, Zdaily, BigNHard, Enhancerol…
The FDA Supports Research to Reduce Health Disparities
The U.S. Food and Drug Administration funds research that can help improve the understanding of health disparities among racial and ethnic minorities—and is committed to protecting the public health of all Americans. Get Consumer Updates by email. Scientific researchers now are working on an important topic: how to reduce health…