Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

2,152 results found for contamination Page 57 of 87
the Compounder
Class II Terminated
BIEST TD 80/20 (estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) W/V (weight/volume) 2.5MG/ML Transdermal cream, dispensed in a) 3 mL and b) 10 mL prefilled, amber syringes, Rx only, The Com...
Reason: Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
D-0193-2016 November 18, 2015 Aurora, IL
the Compounder
Class II Terminated
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume)...
Reason: Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
D-0200-2016 November 18, 2015 Aurora, IL
the Compounder
Class II Terminated
BIEST 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 Ma...
Reason: Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
D-0189-2016 November 18, 2015 Aurora, IL
the Compounder
Class II Terminated
BIEST 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...
Reason: Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
D-0211-2016 November 18, 2015 Aurora, IL
the Compounder
Class II Terminated
BIEST 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.
Reason: Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
D-0186-2016 November 18, 2015 Aurora, IL
the Compounder
Class II Terminated
BIEST 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 on...
Reason: Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
D-0210-2016 November 18, 2015 Aurora, IL
the Compounder
Class II Terminated
ESTRIOL (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 p...
Reason: Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
D-0217-2016 November 18, 2015 Aurora, IL
the Compounder
Class II Terminated
ESTRIOL (E3) 4.0MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Reason: Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
D-0214-2016 November 18, 2015 Aurora, IL
the Compounder
Class II Terminated
ESTRIOL (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,...
Reason: Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
D-0220-2016 November 18, 2015 Aurora, IL
the Compounder
Class II Terminated
BIEST TD 80/20 (Estradiol (E2) Trit (yellow) / Estriol USP Micronized (E3)): PROG (Progesterone USP Micronized) W/V 2.5MG:100MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx o...
Reason: Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
D-0196-2016 November 18, 2015 Aurora, IL
the Compounder
Class II Terminated
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) IN VERSABASE W/V (weight/volume) 4 : 67.5 :10...
Reason: Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
D-0203-2016 November 18, 2015 Aurora, IL
the Compounder
Class II Terminated
BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 0.25 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 3...
Reason: Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
D-0191-2016 November 18, 2015 Aurora, IL
the Compounder
Class II Terminated
ESTRIOL (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 10...
Reason: Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
D-0224-2016 November 18, 2015 Aurora, IL
the Compounder
Class II Terminated
TRIEST 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 Avenu...
Reason: Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
D-0226-2016 November 18, 2015 Aurora, IL
the Compounder
Class II Terminated
ESTRIOL (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 p...
Reason: Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
D-0218-2016 November 18, 2015 Aurora, IL
the Compounder
Class II Terminated
TRIEST 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.
Reason: Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
D-0227-2016 November 18, 2015 Aurora, IL
the Compounder
Class II Terminated
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume)...
Reason: Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
D-0198-2016 November 18, 2015 Aurora, IL
the Compounder
Class II Terminated
BIEST 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 Ma...
Reason: Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
D-0209-2016 November 18, 2015 Aurora, IL
the Compounder
Class II Terminated
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) W/V (weight/volume) 5 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Mar...
Reason: Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
D-0194-2016 November 18, 2015 Aurora, IL
the Compounder
Class II Terminated
ESTRIOL (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.
Reason: Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
D-0222-2016 November 18, 2015 Aurora, IL
Tribute Pharmaceuticals US Inc.
Class III Terminated
Fenofibric Acid Tablets, 35 mg, 30-count bottles, labeled as a) FIBRICOR (fenofibric acid) Tablets, NDC 13310-101-07, UPC 3 13310-101-07 8, Manufactured for: AR SCIENTIFIC, INC., Philadelphia, PA 191...
Reason: Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product.
D-0016-2016 October 21, 2015 Charlotte, NC
Tribute Pharmaceuticals US Inc.
Class III Terminated
Fenofibric Acid Tablets 105 mg, Rx only, labeled as a) FIBRICOR (fenofibric acid) Tablets, 30-count bottles, NDC 13310-102-07, UPC 3 13310-102-07 5; b) FIBRICOR (fenofibric acid) Tablets, 90-count bot...
Reason: Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product.
D-0017-2016 October 21, 2015 Charlotte, NC
Midway Importing, Inc
Class II Terminated
Sedalmex (Acetaminophen 500 mg with Caffeine 65 mg) Pain Reliever tablets, 20-count tablets in blisters per box, Manufactured in Mexico by: Merck, S.A. de C.V./, Imported & Distributed by Midway Impor...
Reason: Cross Contamination With Other Products: Potential cross-contamination of cephalosporin.
D-0013-2016 October 21, 2015 Houston, TX
EMD Serono, Inc.
Class III Terminated
ClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count (2 foil sealed plastic trays of 5 tablets each) per carton, Rx only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD., Jerusalem, 91010, Israel...
Reason: Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.
D-1813-2015 September 23, 2015 Rockland, MA
Mutual Pharmaceutical Company, Inc.
Class III Terminated
Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-913-01
Reason: Chemical Contamination; benzophenone leached from the product label varnish
D-1424-2015 September 16, 2015 Philadelphia, PA