Drug and pharmaceutical recalls
17732 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2015-11-25FDA-DrugPar Pharmaceutical Inc.Class IIIMeclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-035-01) and b) 1000 Ct Bottles (NDC: 49884-035-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
Failed Impurities/Degradation Specifications: Out of specification for impurities.
- 2015-11-25FDA-DrugPar Pharmaceutical Inc.Class IIIMeclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct Bottles (NDC: 49884-034-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
Failed Impurities/Degradation Specifications: Out of specification for impurities.
- 2015-11-25FDA-DrugVintage Pharmaceuticals LLC, DBA Qualitest PharmaceuticalsClass IIHYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 3000 count bottles, Rx only, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, NDC: 0603-3855-93.
Presence of Particulate Matter.
- 2015-11-25FDA-DrugAkorn, Inc.Class IIIRIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42.
Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.
- 2015-11-18FDA-DrugThe One Minute Miracle IncClass IMIRACLE DIET 30 capsules, 30-count bottle, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 7 538073516768.
Marketed Without An Approved NDA/ANDA: Miracle Diet 30 was found to contain undeclared phenolphthalein, a drug product once contained in over-the-counter laxatives but was taken off the U.S. market due to safety concerns, making this product an unapproved drug.
- 2015-11-18FDA-DrugThe One Minute Miracle IncClass IMIRACLE ROCK 48 capsules, packaged in 2 x 2-count blisters, 4-count capsules per carton, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 0911312397354.
Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain undeclared thiosildenafil, an analogue of an FDA approved drug for male erectile dysfunchtion making this product an unapproved drug.
- 2015-11-18FDA-Drugthe CompounderClass IITRIEST 80/10/10 (Estrone (E1) Trit / Estradiol (E2) Trit / Estriol USP (E3)) 1.875MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- 2015-11-18FDA-Drugthe CompounderClass IITRIEST 80/10/10 (E1/E2 Trit - Estrone (E1)/Estradiol (E2) / Estriol USP (E3)) (23) 5MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- 2015-11-18FDA-Drugthe CompounderClass IITRIEST 70/20/10 ( Estriol USP / Estradiol USP (E2) / Estrone (E1) Triturate) [909] 12.5MG/ML transdermal cream, dispensed in 1 mL prefilled amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- 2015-11-18FDA-Drugthe CompounderClass IIESTRIOL 5 ESTRADIOL (Estradiol (E2) Trit (Yellow)) 0.95 ESTRONE (Estrone E1) Trit (Red)) 0.02 TEST (Testosterone USP) 0.75MG/ML W/V (weight/volume) transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- 2015-11-18FDA-Drugthe CompounderClass IIESTRIOL (E3) W/V (weight/volume) VERSABASE [4714] 0.05% (0.5MG/ML) transdermal cream, dispensed in a) 1 mL and b) 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- 2015-11-18FDA-Drugthe CompounderClass IIESTRIOL (E3) W/V (weight/volume) VERSABASE 3MG/ML Transdermal cream, dispensed in 5 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- 2015-11-18FDA-Drugthe CompounderClass IIESTRIOL (E3) W/V (weight/volume) PGF 0.1% (1.0MG/ML) Transdermal cream, is dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- 2015-11-18FDA-Drugthe CompounderClass IIESTRIOL (E3) 2.5MG suppositories, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- 2015-11-18FDA-Drugthe CompounderClass IIESTRIOL (E3) : TESTO (Testosterone USP) WV (weight/volume) 0.5MG : 2MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- 2015-11-18FDA-Drugthe CompounderClass IIESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : TESTO (Testosterone USP) W/V (weight/volume) 2.0: 0.1: 0.5MG/ML Transdermal cream, dispensed in 5 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- 2015-11-18FDA-Drugthe CompounderClass IIESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : PROGEST (Progesterone USP) : TESTO (Testosterone USP) W/V (weight/volume) 2 :0.1 : 30 : 0.5 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- 2015-11-18FDA-Drugthe CompounderClass IIESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : PROGEST (Progesterone USP) : TESTO (Testosterone USP) W/V (weight/volume) 2 :0.1 : 35 : 0.5 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- 2015-11-18FDA-Drugthe CompounderClass IIESTRIOL (E3) : PROGESTERONE W/V (weight/volume) 4.0 : 100 MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- 2015-11-18FDA-Drugthe CompounderClass IIESTRIOL (E3) : PROGESTERONE : DHEA (Dehydroepiandrosterone Micronized) W/V (weight/volume) VERSABASE 4.0 : 30 : 4MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- 2015-11-18FDA-Drugthe CompounderClass IIESTRIOL (E3) 4.0MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- 2015-11-18FDA-Drugthe CompounderClass IIE2 (Estradiol (E2) Trit (Yellow) : E3 (Estriol USP Micronized (E3) : PROGEST (Progesterone USP Micronized) : TESTOST (Testosterone USP) IN OLIVE OIL 0.75 : 3 : 50 : 5MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- 2015-11-18FDA-Drugthe CompounderClass IIBIEST TD 91/9 (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow)) : PROGESTERONE W/V (weight/volume) PLO (Pluronic F127 20% or Polox 20% gel) 3.3 MG/ML : 40 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- 2015-11-18FDA-Drugthe CompounderClass IIBIEST TD 89/11 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) W/V (weight/volume) VERSABASE 2.25MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- 2015-11-18FDA-Drugthe CompounderClass IIBIEST TD 86/14 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) IN PLO GEL (Pluronic F127 20% or Polox 20% gel) 2.9 MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only,The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- 2015-11-18FDA-Drugthe CompounderClass IIBIEST TD 83/17 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) W/V (weight/volume) 1.2 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- 2015-11-18FDA-Drugthe CompounderClass IIBIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) VAN CR (vanishing cream) W/V (weight/volume) (4812) 2.5MG/ML Transdermal cream, dispensed in a) 1mL and b)3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- 2015-11-18FDA-Drugthe CompounderClass IIBIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : TESTO (Testosterone USP) W/V (weight/volume) 1.0 :4.0 MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- 2015-11-18FDA-Drugthe CompounderClass IIBIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : TESTO (Testosterone USP) W/V (weight/volume) 1.25:100:0.625 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only,The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- 2015-11-18FDA-Drugthe CompounderClass IIBIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : TESTO (Testosterone USP) W/V (weight/volume) 5.0 :20 :1 MG/ML Transdermal cream, dispensed in 5 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
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