What's New on the FDA Drugs Site
May 5, 2017
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
New and Generic Drug Approvals
May 5, 2017
May 4, 2017
GEC Laxoplex Dietary Supplement Capsules by Genetic Edge Compounds: Recall - Presence of Anabolic Steroids
AUDIENCE: Consumer
ISSUE: Genetic Edge Compounds recalled all lot codes of GEC Laxoplex dietary supplement capsules distributed between February 2, 2015- May 2, 2017 to the retail level and consumer level. FDA analysis found GEC Laxoplex to be tainted with anabolic steroids and steroid like substances. The presence of these anabolic steroids and steroid like substances in GEC Laxoplex renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
Use or consumption of products containing anabolic steroids may cause acute liver injury, which is known to be a possible harmful effect of using steroid containing products. In addition, abuse of anabolic steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death.
BACKGROUND: GEC Laxoplex is marketed as a dietary supplement and sold as a muscle enhancing agent. The product is packaged in a white plastic bottle containing 60 capsules with UPC code 0058049984 and can be identified by GEC Laxoplex. The recall affects all lots of GEC Laxoplex. GEC Laxoplex was distributed Nationwide in the USA through various nutritional supplement retail outlets.
RECOMMENDATION: Genetic Edge Compounds is notifying its retailers and customers by a formal recall notification and is arranging for a return of all recalled products. Consumers and retailers that have GEC Laxoplex dietary supplement capsules which are being recalled should stop using them and return to place of purchase.
Healthcare professionals and patients are encouraged to report adverse events or side effects 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
- 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 a link to the firm's press release, at:
05/08/2017 03:15 PM EDT
Bellmawr, New Jersey, C.O. Truxton, Inc. is expanding their 04/21/2017 voluntary recall, as a precaution to include the following C.O. Truxton, Inc. products, registered NDC numbers and corresponding lot numbers, to the consumer/user level. C.O. Truxton has not received any complaints for the products listed below. however, due to the initial recall resulting from a label mix-up error, out of an abundance of caution, we are recalling all products that were repackaged into a Truxton Incorporated label.
For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.
05/05/2017 08:39 PM EDT
Smallbatch Pets Inc. of Portland, Oregon is voluntarily recalling two lots of frozen 2lbs. chicken blend for dogs and cats, brand name Smallbatch, due to the potential to be contaminated with Salmonella.
For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.
05/05/2017 06:34 PM EDT
Pinnacle Foods Inc. is voluntarily recalling all “Best By” dates of Aunt Jemima Frozen Pancakes, Frozen Waffles & Frozen French Toast Slices distributed nationally in the United States and one product into Mexico because they have the potential to be contaminated with Listeria monocytogenes. No illnesses have been reported. The products are being recalled as a precautionary measure given the health and safety of our consumers is our top priority. Pinnacle Foods initiated the recall after testing indicated the presence of Listeria monocytogenes in the plant environment.
For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.
05/05/2017 06:35 PM EDT
Genetic Edge Compounds is voluntarily recalling all lot codes distributed between February 2, 2015- May 2, 2017 of GEC Laxoplex dietary supplement capsules, packaged in a white plastic bottle containing 60 capsules to the retail level and consumer level. Food and Drug Administration (“FDA”) analysis has found GEC Laxoplex to be tainted with anabolic steroids and steroid like substances.
For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.
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