Drug and pharmaceutical recalls
17628 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2015-11-18FDA-Drugthe CompounderClass IIBIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 8 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 67/33 (Estradiol (E2) TRIT (YELLOW)/Estriol USP Micronized (E3)) W/V (weight /volume) 1.5 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 50/50 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 4.0 MG/ML transdermal cream packaged in 3mL 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 50/50 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 2.5 MG/ML transdermal cream, dispensed in 10 mL prefilled 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 CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 2.5 MG 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 CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 1.25 MG 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 CP 76/24: DHEA (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow) : Dehydroepiandrosterone Micronized (DHEA) 2.625 MG : 10 MG 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 80/20 : PROGEST : DHEA : TESTOST (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow): Progesterone USP: Dehydroepiandrosterone Micronized (DHEA): Testosterone Trit ) 2.5 : 25 : 2.5 : 0.1MG TROCHE, 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 66/34: TESTOSTERONE : PROGESTERONE IN OLIVE OIL(Estradiol USP Micronized (ED)/Estriol USP Micronized (E3): Testosterone : Progesterone in Olive Oil) 3mg : 4 mg : 100 mg/mL suspension, Rx only, packaged in a 15 mL glass dropper bottle. 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-DrugBreckenridge Pharmaceutical, IncClass IIIDuloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr. Esteve, S.A., Barcelona, Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, NDC: 51991-748-10
Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
- 2015-11-18FDA-DrugPacific Healthcare, Inc dba B&B PharmacyClass IIPGE 25mcg/ml, Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-11-18FDA-DrugPacific Healthcare, Inc dba B&B PharmacyClass IIPAPA/PGE1/PHENTO (35mg/12mcg/1.5mg/ml), Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-11-18FDA-DrugPacific Healthcare, Inc dba B&B PharmacyClass IIPAPA/PHENTO (15mg/0.8333mg/ml) Injection, 5 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-11-18FDA-DrugPacific Healthcare, Inc dba B&B PharmacyClass IIPGE 30mcg/ml Injection, 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-11-18FDA-DrugPacific Healthcare, Inc dba B&B PharmacyClass IIPAPA/PGE1/PHENTO (15mg/5mcg/0.5mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-11-18FDA-DrugPacific Healthcare, Inc dba B&B PharmacyClass IIPAPA/PGE1/PHENTO (30mg/40mcg/1mg/ml) Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-11-18FDA-DrugPacific Healthcare, Inc dba B&B PharmacyClass IIPAPA/PGE1/PHENTO (30mg/10mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-11-18FDA-DrugPacific Healthcare, Inc dba B&B PharmacyClass IIPAPA/PGE1/PHENTO (22.5mg/8.33mcg/0.833mg/ml) Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-11-18FDA-DrugPacific Healthcare, Inc dba B&B PharmacyClass IIPAPA/PGE1/PHENTO (30mg/50mcg/0.5mg/ml), Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-11-18FDA-DrugPacific Healthcare, Inc dba B&B PharmacyClass IIPGE 20mcg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-11-18FDA-DrugPacific Healthcare, Inc dba B&B PharmacyClass IIPAPA/PHENTO (30mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-11-18FDA-DrugPacific Healthcare, Inc dba B&B PharmacyClass IIPAPA+PGE1+PHENTO (30mg/20mcg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-11-18FDA-DrugPacific Healthcare, Inc dba B&B PharmacyClass IITestosterone prop. 200 mg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-11-18FDA-DrugPacific Healthcare, Inc dba B&B PharmacyClass IITestosterone Cypionate 250 mg/mL Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-11-18FDA-DrugPacific Healthcare, Inc dba B&B PharmacyClass IINandrolone 200 mg/ml Injection, 10 mL and 20 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-11-18FDA-DrugPacific Healthcare, Inc dba B&B PharmacyClass IIStanozolol 200 mg/ml Injection, 20 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-11-18FDA-DrugC. O. TruxtonClass IIDoxycycline Hyclate Tablets, USP, 100 mg, 500-count bottle, Rx only, Distributed by: Truxton Inc. Bellmawr, NJ 08031, Manufactured for: Blu Caribe Dorado, PR 00646 USA, NDC 0463-6000-50 (top panel) NDC 24658-312-05 (side panel)
Labeling: Wrong Bar Code
- 2015-11-11FDA-DrugValeant Pharmaceuticals North America LLCClass IIFenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, Inc. San Diego, CA 92130. NDC: 68012-495-90.
Failed Dissolution Specifications: Failed 24 month dissolution testing.
- 2015-11-11FDA-DrugVintage Pharmaceuticals LLC, DBA Qualitest PharmaceuticalsClass IIIRANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-9418-58.
Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
- 2015-11-04FDA-DrugPfizer Inc.Class IIXanax (alprazolam) tablets, 0.25 mg, 100-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co. Division of Pfizer Inc, NY, NY 10017, NDC 0009-0029-01
Subpotent Drug
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