Public Health Trace republishes official recall, outbreak, and surveillance data from CDC, FDA, USDA,
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Showing 15,221–15,240 of 17,987 drug recalls
Drug RecallTerminatedHistorical recordClass I
MiracleZEN Platinum, 1 pill blister pack, 2000 mg capsule, Distributed by: Power Life Distributors, COK Inc., Los Angeles, CA.
by Schindele Enterprises dba Midwest Wholesale
Reason
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Recall initiated
January 9, 2014
Reported by FDA
May 28, 2014
Distribution
Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI
BOOST ULTRA, sexual enhancement dietary supplement, 12-capsule/bottle. Also packaged in 3 pill bottles and 1 pill packs. BoostUtra.com, Springfield, MO.
by Schindele Enterprises dba Midwest Wholesale
Reason
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Recall initiated
January 9, 2014
Reported by FDA
May 28, 2014
Distribution
Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI
Esbelder Fem Mezcla con L-Carnitina Suplemento Alimenticio,30 capsule bottle, Hecho en Mexico: Soluciones HGC S. de R.L. de C.V. Av. Independencia #1060 Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000251
by Herbal Give Care Llc
Reason
Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Recall initiated
July 19, 2013
Reported by FDA
May 28, 2014
Distribution
Products were sold to distributors nationwide. Recalling firm sold some product directly to consumers.
Esbelder Man Herbal Blend With L-Carnitine Dietary Supplement, 30 capsule bottle, Made in Mexico: Soluciones S. de R.L. de C.V. Av. Independencia #1060 Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000275
by Herbal Give Care Llc
Reason
Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Recall initiated
July 19, 2013
Reported by FDA
May 28, 2014
Distribution
Products were sold to distributors nationwide. Recalling firm sold some product directly to consumers.
Esbelder Siloutte Suplemento Alimenticio, 30 capsule bottle, Hecho en Mexico Por: Herbal Give Care, Av Independencia # 1016, Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000268
by Herbal Give Care Llc
Reason
Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Recall initiated
July 19, 2013
Reported by FDA
May 28, 2014
Distribution
Products were sold to distributors nationwide. Recalling firm sold some product directly to consumers.
Esbelin Siloutte Te, Suplemento Alimenticio, herbal tea in a gold foil/plastic zip-lock pouch. Hecho en Mexico Por: Herbal Give Care, Av Independencia # 1016, Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7562684652553
by Herbal Give Care Llc
Reason
Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Recall initiated
July 19, 2013
Reported by FDA
May 28, 2014
Distribution
Products were sold to distributors nationwide. Recalling firm sold some product directly to consumers.
Esbelin Siloutte Mezcal Herbal con L-Carnitine Suplemento Alimenticio, 30 capsule bottle, Hecho En Mexico Por: Soluciones HGC S. de R.L. de C.V. Av. Independicia #1016 Frac. La Rinconada Aguascalientes, Ags. Mex C.P. 20136, UPC 7502011000060
by Herbal Give Care Llc
Reason
Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Recall initiated
July 19, 2013
Reported by FDA
May 28, 2014
Distribution
Products were sold to distributors nationwide. Recalling firm sold some product directly to consumers.
Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg, packaged in a) 30-count Unit of Use bottles (NDC 0008-0836-21) UPC 3 0008-0836-21 7; b) 90-count Unit of Use bottles (NDC 0008-0836-22) UPC 3 0008-0836-22 4; Rx only, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101.
by Pfizer Us Pharmaceutical Group
Reason
Presence of Foreign Tablets/Capsules: A Pharmacist reported that a bottle of Effexor XR 150 mg capsules contained a single peach colored capsule printed TKN250 which was identified as a Tikosyn (dofetilide) capsule.
PRO ArthMax Dietary Supplement tablets, 750 mg, 120 count bottles, Distributed by Human Science Foundation, Los Angeles, CA
by HUMAN SCIENCE FOUNDATION
Reason
Marketed without an Approved NDA/ANDA; FDA analysis found the product to contain Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin
Smart Tab First Aid ezRefill System Ibuprofen dispenser boxes (Item Number FAE 7014), 20 count boxes, First Aid Only Inc., Vancouver, WA
by First Aid Only Inc
Reason
First Aid Only, Inc is recalling Smart Tab First Aid ezRefill System Ibuprofen boxes and First Aid Cabinets containing these Ibuprofen boxes. Ibuprofen boxes (FAE 7014) were accidentally used to package aspirin packs (10 packs of 2 / 235mg tablets).
Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manufactured and Distributed by: Euro Med Laboratories, UPC 4800573016219
by Flawless Beauty LLC
Reason
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection.
Vitamin C (ascorbic acid) Injection, USP, 500 mg per 2 mL, 50 x 2 mL ampoules per box, Manufactured by: TP Drug Laboratories (1969) Co., Ltd., 98 Soi Sukhumvlt 62, Yak 1, Bangchak, Prakanong, Bangkok 10260, Thailand, Reg. No. 1 A 1557/30; UPC 8 853533 000533
by Flawless Beauty LLC
Reason
Marketed Without An Approved NDA/ANDA: Parenteral product is sold over the counter whose labeling indicates it is to be used for the treatment of disease.
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer.
