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Alternative EQUATE Names:ACETAMINO ALUMINUM ASPIRIN AVOBENZON BACITRACI BENZOCAIN BENZOYL P BISMUTH S BROMPHENI CALCIUM C CALCIUM P CAMPHOR, CARBOXYME CETIRIZIN COCOA BUT DEXTROMET DEXTROSE DIPHENHYD DOXYLAMIN ENSULIZOL FAMOTIDIN FEXOFENAD GLYCERIN, GUAIFENES HYDROCORT IBUPROFEN KETOTIFEN LANOLIN, LOPERAMID LORATADIN MAGNESIUM MENTHOL MICONAZOL MINERAL O MINOXIDIL NAPROXEN NEOMYCIN, NICOTINE OCTINOXAT OMEPRAZOL OXYMETAZO PHENOL PHENYLEPH PIPERONYL POLYETHYL PSEUDOEPH PSYLLIUM RANITIDIN SALICYLIC SALINE SELENIUM SIMETHICO TERBINAFI TIOCONAZO TOLNAFTAT TRICLOSAN WITCH HAZ ZINC OXID
Active Ingredient: ACETAMINO ALUMINUM ASPIRIN AVOBENZON BACITRACI BENZOCAIN BENZOYL P BISMUTH S BROMPHENI CALCIUM C CALCIUM P CAMPHOR ( CARBOXYME CETIRIZIN COCOA BUT DEXTROMET DEXTROSE; DIMETHICO DIPHENHYD DOXYLAMIN ENSULIZOL FAMOTIDIN FEXOFENAD GLYCERIN; GUAIFENES HYDROCORT IBUPROFEN KETOTIFEN LANOLIN; LOPERAMID LORATADIN MAGNESIUM MENTHOL MICONAZOL MINERAL O MINOXIDIL NAPROXEN NEOMYCIN NICOTINE OCTINOXAT OMEPRAZOL OXYMETAZO PHENOL PHENYLEPH PIPERONYL POLYETHYL PSEUDOEPH PSYLLIUM RANITIDIN SALICYLIC SELENIUM SODIUM PH TERBINAFI TIOCONAZO TOLNAFTAT TRICLOSAN WITCH HAZ ZINC OXID
Side Effects reported to FDA: 499. View Equate Adverse Reports
Equate safety alerts: 2011
Reported hospitalizations: 2
H & P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel: Recall - Inadequate Microbial Testing
Multiple brands affected - listed below
[UPDATED 09/25/2012] Custom Medical Specialties, Inc., Custom HSG Tray, Hysteroscopic Sterilization Pack, Custom Vein Tray, Custom Amnio Tray, Fox Chase Specials Pack, Abington Radiology Drainage Pack, Custom CT Biopsy Tray, HSG Tray, Custom Myelogram Tray, and Hysteroscopy Sterile Procedure Kit. Class 1 Recall. The custom surgical kits contain Povidone Iodine Prep solution that had previously been recalled by H & P Industries, Inc. The manufacturer did not conduct any microbial testing and the products did not meet proper finished specifications. These products may cause serious adverse health consequences, including death. See the Recall Notice for a listing of affected brand names and lot numbers.
ISSUE: H & P Industries and FDA notified health professionals and the public of a recall of all lots (lots beginning with 8J-8M, 9A-9M, 0A-0M, 1A-1C) of Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel. H & P Industries, Inc. manufactured these Povidone Iodine products without having in place a system for microbial testing at the time of release, without having a system for testing of incoming components, and without having procedures designed and established to prevent objectionable microorganisms in these drug products. Patients undergoing medical and surgical procedures, including those who are immunocompromised, have a high risk of infection from antiseptic surgical preparations that have been prepared, packaged, or held under insanitary conditions. This recall has been initiated at the request of FDA.
BACKGROUND: Povidone Iodine Swabsticks, Povidone Iodine Prep Solutions, Povidone Iodine Scrub Solutions, and Povidone Iodine Prep Gel are labeled as an antiseptic for preparation of the skin prior to surgery, and are used to prevent infection in minor cuts, scrapes and burns. The Povidone Iodine Scrub solutions are labeled also for use as a surgical hand scrub for health care professionals. The Povidone Iodine products were distributed nationwide to healthcare customers. The swabsticks are packaged in individual packets of 1 or 3 swabs and the Prep Solution, Scrub Solution and Prep Gel are sold in bottles.
RECOMMENDATION: Specific customers distributing the product and selling it at the wholesale and hospital level are being notified by e-mail with instructions on how to return the product. Consumers that have any of these types of products in their possession should not use the product and should return it to the place it was purchased.
[09/25/2012 - Recall Notice - FDA]
[08/24/2011 - Press Release - H&P Industries, Inc]
Have Your experienced Equate Side Effects? You are not alone. Many patients report unusual symptoms after using Equate. PatientsVille.com raises awareness about Drug Side Effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.