Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1066-2015 | 03-17-2015 | Methylcobalamin/Hydroxocobalamin Rx 3.125/3.125 mg/0.5 mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Lack of assurance of sterility | Fallon Wellness Pharmacy, L.L.C. / 30 vials | Class II | Terminated |
| D-1073-2015 | 03-17-2015 | Papaverine/phentolamine/prostaglandin 30/1/0.01mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Lack of assurance of sterility | Fallon Wellness Pharmacy, L.L.C. / 8 vials | Class II | Terminated |
| D-1068-2015 | 03-17-2015 | Prostaglandin Rx, dispensed in 5 ml vials: 1) 10 mcg/mL Injection, 2) 22.5 mcg/mL Injection, 3) 45 mcg/mL Injection, 4) 60 mcg/mL Injection, 5) 80 mcg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Lack of assurance of sterility | Fallon Wellness Pharmacy, L.L.C. / 43 vials | Class II | Terminated |
| D-1069-2015 | 03-17-2015 | Papaverine/phentolamine/prostaglandin 30/4/0.04 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Lack of assurance of sterility | Fallon Wellness Pharmacy, L.L.C. / 15 vials | Class II | Terminated |
| D-1070-2015 | 03-17-2015 | Papaverine/phentolamine/prostaglandin 30/1/0.02 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Lack of assurance of sterility | Fallon Wellness Pharmacy, L.L.C. / 8 vials | Class II | Terminated |
| D-1067-2015 | 03-17-2015 | Methylcobalamin/B-Complex Rx 2.5/103 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Lack of assurance of sterility | Fallon Wellness Pharmacy, L.L.C. / 12 vials | Class II | Terminated |
| D-0995-2015 | 03-17-2015 | SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0823-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701 | Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. | Akorn, Inc. / 27,648 bottles (16 fl. oz. each) | Class II | Terminated |
| D-1071-2015 | 03-17-2015 | Papaverine/phentolamine/prostaglandin 30/1/0.025 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Lack of assurance of sterility | Fallon Wellness Pharmacy, L.L.C. / 6 vials | Class II | Terminated |
| D-1074-2015 | 03-17-2015 | Methylcobolamin 1) 6500 mcg/0.26mL, 2) 1000 mcg/0.08mL, 3) 5000mcg/mL, 4) 3000mcg/0.12mL, 5) 4000mcg/0.16mL, 6) 1000mcg/mL and 7) 1000 mcg/0.04mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Lack of assurance of sterility | Fallon Wellness Pharmacy, L.L.C. / 56 vials | Class II | Terminated |
| D-0996-2015 | 03-17-2015 | SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GRAPE FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0824-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701 | Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. | Akorn, Inc. / 326,666 bottles (16 fl. oz. each) | Class II | Terminated |
| D-0975-2015 | 03-12-2015 | Captopril Tablets, USP 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-01, b) 1000 count bottles NDC 64679-902-02, Manufactured by Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt USA LLC., 20 Waterview Boulevard, Parsippany, NJ 07054 USA | Failed Tablet/Capsule Specifications: out of specification for thickness. | Wockhardt Usa Inc. / 93,393 bottles | Class II | Terminated |
| D-1108-2015 | 03-11-2015 | LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7828-08. | Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently identified as mold | Hospira Inc. / 24,744 flexible container bags | Class I | Terminated |
| D-0435-2015 | 03-11-2015 | Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy, Original Prescription Strength, a) 60 count Bottles, NDC 0378-0781-91, b) 500 count Bottles, NDC 0378-0781-05, Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, USA. | Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine. | Mylan Pharmaceuticals Inc. / 13,856 Bottles | Class III | Terminated |
| D-0197-2016 | 03-10-2015 | 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) VERSABASE 2.5: 30 : 2.5 : 0.25 MG/MLTransdermal 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. | the Compounder / 18 (10mL) syringes | Class II | Terminated |
| D-0213-2016 | 03-10-2015 | E2 (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. | the Compounder / 120 capsules | Class II | Terminated |
| D-0414-2015 | 03-10-2015 | Ergoloid Mesylates ,1 mg tablets, 100 count bottle, Rx only, Manufactured by MUTUAL PHARMACEUTICAL CO., INC., PHILADELPHIA, PA 19124 USA for Sun Pharmaceutical Industries, Inc. 270 Prospect Plains Road, Cranbury, NJ 08512. NDC 53489-281-01 | Failed Impurities/Degradation Specifications: during long-term stability testing. | Mutual Pharmaceutical Company, Inc. / 23246 bottles | Class II | Terminated |
| D-0423-2015 | 03-10-2015 | AIR COMPRESSED, Medical Air, USP, Rx Only. Matheson Tri-Gas, Inc., 150 Allen Road, Basking Ridge, NJ 07920. Available in A) E or 22 cu ft cylinder, NDC: 55037-302-09; B) 40 cu ft cylinder, NDC: 55037-302-10; C) 200 cu ft cylinder, NDC: 55037-302-15; D) 220 cu ft cylinder, NDC: 55037-302-16; E) 300 cu ft cylinder, NDC: 55037-302-18, 55037-302-19, 55037-302-20. Package NDCs: 55037-302-01; 55037-302-02; 55037-302-03; 55037-302-04; 55037-302-05; 55037-302-06; 55037-302-07; 55037-302-08; 55037-302-09; 55037-302-10; 55037-302-11; 55037-302-12; 55037-302-13; 55037-302-14; 55037-302-15; 55037-302-16; 55037-302-17; 55037-302-18; 55037-302-19; 55037-302-20 | Failed Impurities/Degradation Specification; out of specification results for carbon dioxide | Matheson, Inc. / 137,880 cubic feet | Class III | Terminated |
| D-0228-2016 | 03-10-2015 | TRIEST 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. | the Compounder / 60 capsules | Class II | Terminated |
| D-0211-2016 | 03-10-2015 | 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, 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. | the Compounder / 10 (3mL) syringes | Class II | Terminated |
| D-0214-2016 | 03-10-2015 | ESTRIOL (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. | the Compounder / 90 capsules | Class II | Terminated |
| D-0199-2016 | 03-10-2015 | 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) 2.5 : 20 : 1.25 : 0.25 MG/ML TRANSDERMAL (Cream)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. | the Compounder / 6 (10mL) syringes | Class II | Terminated |
| D-0222-2016 | 03-10-2015 | 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. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 10 (3mL) syringes | Class II | Terminated |
| D-0185-2016 | 03-10-2015 | BIEST 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. | the Compounder / 240 capsules | Class II | Terminated |
| D-0186-2016 | 03-10-2015 | 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. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 180 capsules | Class II | Terminated |
| D-0194-2016 | 03-10-2015 | 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 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. | the Compounder / 6 (10mL) syringes | Class II | Terminated |
| D-0212-2016 | 03-10-2015 | BIEST 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. | the Compounder / 10 (10mL) syringes | Class II | Terminated |
| D-0209-2016 | 03-10-2015 | 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 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. | the Compounder / 6 (10mL) syringes | Class II | Terminated |
| D-0188-2016 | 03-10-2015 | BIEST 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. | the Compounder / 5 (3mL) syringes | Class II | Terminated |
| D-0192-2016 | 03-10-2015 | BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 12.5 MG/ML 1.25MG/0.1ML 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. | the Compounder / 9 (1mL) syringes | Class II | Terminated |
| D-0567-2016 | 03-10-2015 | Domperidone BP, Active Pharmaceutical Ingredient for Prescription Compounding, packaged in a) 5 gm (NDC: 52372-0898-01), b) 25 gm (NDC: 52372-0898-02), c) 100 gm (NDC: 52372-0898-03), and d) 500 gm (NDC: 52372-0898-04), Cas No. 57808-66-9, Rx only, FREEDOM, 801 W. New Orleans St., Broken Arrow, OK 74011. | Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin. | Freedom Pharmaceuticals Inc / 20 kg | Class II | Terminated |
| D-0203-2016 | 03-10-2015 | 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 :10MG/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. | the Compounder / 18 (10mL) syringes | Class II | Terminated |
| D-0195-2016 | 03-10-2015 | BIEST TD 80/20 (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow)) W/V(weight/volume) [2977] 6.25MG/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. | the Compounder / 36 (1 mL) syringes | Class II | Terminated |
| D-0205-2016 | 03-10-2015 | BIEST 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. | the Compounder / 15 (5mL) syringes | Class II | Terminated |
| D-0207-2016 | 03-10-2015 | BIEST 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. | the Compounder / 5 (3mL) syringes | Class II | Terminated |
| D-0196-2016 | 03-10-2015 | 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 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. | the Compounder / 15 (3 mL) syringes | Class II | Terminated |
| D-0225-2016 | 03-10-2015 | ESTRIOL 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. | the Compounder / 20 (10mL) syringes | Class II | Terminated |
| D-0226-2016 | 03-10-2015 | 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 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. | the Compounder / 24 (1mL) syringes | Class II | Terminated |
| D-0991-2015 | 03-10-2015 | ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semilla de Sen 47.6, Lagrima de Coix 42, Almidon Medico 84), 30 capsule bottles, Manufactured and distributed by: Ultra ZX Labs, L.L.C. 2525 SW 3rd Ave Apt 1704 Miami, Florida 33129-2068. | Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein | Ultra ZX Supplements / 636 bottles | Class I | Terminated |
| D-0208-2016 | 03-10-2015 | BIEST 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. | the Compounder / 1(1mL) syringe, 56 (3mL) syringes | Class II | Terminated |
| D-0190-2016 | 03-10-2015 | BIEST 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. | the Compounder / 5 (3mL) syringes | Class II | Terminated |
| D-0193-2016 | 03-10-2015 | 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 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. | the Compounder / 30 (3mL) syringes, 9 (10mL) syringes | Class II | Terminated |
| D-0224-2016 | 03-10-2015 | 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 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 10 (3mL) syringes, 20 (1mL) syringes | Class II | Terminated |
| D-0200-2016 | 03-10-2015 | 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) VERSABASE 3: 25: 1.25: 0.25 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. | the Compounder / 12 (10mL) syringes | Class II | Terminated |
| D-0221-2016 | 03-10-2015 | ESTRIOL (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. | the Compounder / 20 suppositories | Class II | Terminated |
| D-0217-2016 | 03-10-2015 | 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 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. | the Compounder / 6 (10mL) syringes | Class II | Terminated |
| D-0219-2016 | 03-10-2015 | ESTRIOL (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. | the Compounder / 9 (5mL) syringes | Class II | Terminated |
| D-0216-2016 | 03-10-2015 | ESTRIOL (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. | the Compounder / 40 (3mL) syringes | Class II | Terminated |
| D-0201-2016 | 03-10-2015 | 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) VERSABASE 6.5 : 30: 1.25: 0.25 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. | the Compounder / 12 (10mL) syringes | Class II | Terminated |
| D-0223-2016 | 03-10-2015 | ESTRIOL (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. | the Compounder / 6 (5mL) syringes | Class II | Terminated |
| D-0215-2016 | 03-10-2015 | ESTRIOL (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. | the Compounder / 3 (10mL) syringes | Class II | Terminated |
| D-0210-2016 | 03-10-2015 | 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 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. | the Compounder / 20 (3mL) syringes | Class II | Terminated |
| D-0191-2016 | 03-10-2015 | 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, 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. | the Compounder / 6 (10mL) syringes | Class II | Terminated |
| D-0198-2016 | 03-10-2015 | 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) VERSABASE 5.0 : 30 : 2.5 : 0.25 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. | the Compounder / 26 (10mL) syringes | Class II | Terminated |
| D-0187-2016 | 03-10-2015 | BIEST 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. | the Compounder / 3 (10mL) syringes | Class II | Terminated |
| D-0206-2016 | 03-10-2015 | BIEST 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. | the Compounder / 12 (10mL) syringes | Class II | Terminated |
| D-0183-2016 | 03-10-2015 | BIEST 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. | the Compounder / 60 troches | Class II | Terminated |
| D-0189-2016 | 03-10-2015 | 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 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. | the Compounder / 10 (3mL) syringes | Class II | Terminated |
| D-0220-2016 | 03-10-2015 | 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, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 30 (3mL) syringes | Class II | Terminated |
| D-0227-2016 | 03-10-2015 | 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. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 120 capsules | Class II | Terminated |
| D-0204-2016 | 03-10-2015 | BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : TESTO (Testosterone USP) : DHEA (Dehydroepiandrosterone Micronized) W/V (weight/volume) VERSABASE 2.5 : 17.5 : 1.25 :0.25MG/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. | the Compounder / 12 (10mL) syringes | Class II | Terminated |
| D-0184-2016 | 03-10-2015 | BIEST 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. | the Compounder / 90 capsules | Class II | Terminated |
| D-0202-2016 | 03-10-2015 | 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) 2.5 : 25 :1.25MG/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. | the Compounder / 66 (10mL) syringes | Class II | Terminated |
| D-0218-2016 | 03-10-2015 | 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 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. | the Compounder / 5 (10mL) syringes | Class II | Terminated |
| D-0182-2016 | 03-10-2015 | BIEST 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. | the Compounder / 3 (15mL) bottles | Class II | Terminated |
| D-0431-2015 | 03-09-2015 | Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, Rx only, Manufactured by: Emcure Pharmaceuticals Lt. for Sandoz Inc., Princeton, NJ 08540, NDC 0781-3182-73 and 0781-3182-84 | Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility. | Navinta LLC / 14,628 units | Class II | Terminated |
| D-0410-2015 | 03-06-2015 | DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) FusePaq, 150 mL Kits, Rx Only. Fusion Pharmaceuticals LLC., 768 Calle Plano, Camarillo, CA 93012. NDC: 43093-104-01. | Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans. | Fusion Pharmaceuticals, LLC / 9,439 Kits | Class II | Terminated |
| D-1076-2015 | 03-06-2015 | MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6727-23, UPC (01) 0 030409 672723 1. Package NDCs: 0409-6727-11; 0409-6727-23; 0409-6727-55; 0409-6727-50 | Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as heparin sodium 2000 USP units/1000 mL in 0.9% in sodium chloride injection. | Hospira Inc. / 181,704 bags | Class I | Terminated |
| D-0417-2015 | 03-05-2015 | 5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026; packaged in 24 bags per case pack (NDC 0409-7100-02), UPC (01)30304097100027(30)01, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045. Package NDCs: 0409-7100-68; 0409-7100-66; 0409-7100-69; 0409-7100-67; 0409-7100-04; 0409-7100-02; 0030404097; 3030409710 | Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container. | Hospira Inc. / 94,440 bags | Class II | Terminated |
| D-0976-2015 | 03-05-2015 | 0.9% Sodium Chloride Injection, USP, 250 mL, Rx only, VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-25. | Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution. | Hospira Inc. / 9,912 VisIV flex containers | Class I | Terminated |
| D-0661-2016 | 03-02-2015 | Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL amber bottle, Rx Only, Manufactured by Silarx Pharmaceuticals Inc. Carmel, NY 10512, Packaged by Safecor Health, Woburn, MA 01801, NDC 54838-0501-40. | Defective Container: Confirmed customer complaints of leaking bottles. | Safecor Health, LLC / 3,532 amber bottles | Class II | Terminated |
| D-1140-2015 | 03-02-2015 | Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton of 30: NDC 68084-0416-21, Individual dose: NDC 68084-0416-11 | Failed dissolution specifications | American Health Packaging / 925 cartons (30 tablets in each carton) | Class II | Terminated |
| D-0405-2015 | 02-27-2015 | Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g that provides 120 actuations, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 for Akorn Inc. 1925 W. Field Court, Suite 300 Lake Forest Illinois, 60045. NDC 50383-700-16. | Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride. | Akorn, Inc. / 44,448 bottles | Class II | Terminated |
| D-0401-2015 | 02-27-2015 | Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026868815, NDC 50268-688-15 | Subpotent Drug | AVKARE Inc. / 214 unit dose packs | Class III | Terminated |
| D-0402-2015 | 02-27-2015 | Quinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026869115, NDC 50268-691-15 | Subpotent Drug | AVKARE Inc. / 431 unit dose packs | Class III | Terminated |
| D-0403-2015 | 02-26-2015 | Oxecta(TM) (oxycodone HCl) tablets, 5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN, NDC 60793-525-01 | Failed Impurities/Degradation Specifications | Pfizer Inc. / 137 bottles | Class III | Terminated |
| D-0404-2015 | 02-26-2015 | Oxecta(TM) (oxycodone HCl) tablets, 7.5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN, NDC 60793-526-01 | Failed Impurities/Degradation Specifications | Pfizer Inc. / 139 bottles | Class III | Terminated |
| D-0485-2015 | 02-25-2015 | Minivelle (estradiol transdermal system) 0.05 mg/day, 8-count box, Rx only, Manufactured by Noven Pharmaceuticals, Inc., Miami, Florida 33186, Distributed by Noven Pharmaceuticals, LLC, Miami, Florida 33186, NDC 68968-6650-8 Package NDCs: 68968-6625-8; 68968-6637-8; 68968-6650-8; 68968-6675-8; 68968-6610-8 | Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions. | Noven Pharmaceuticals, Inc. / 720 transdermal patches | Class II | Terminated |
| D-0416-2015 | 02-25-2015 | RIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724 NDC 23155-340-31 | Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes. | Heritage Pharmaceuticals, Inc. / 24,344 vials | Class II | Terminated |
| D-0415-2015 | 02-25-2015 | Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc. NDC 23155-193-31 Package NDCs: 23155-193-41; 23155-193-31 | Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes. | Heritage Pharmaceuticals, Inc. / | Class II | Terminated |
| D-0965-2015 | 02-24-2015 | Droperidol injection, 2.5 mg/mL, 5 mg Total Dose, 2 mL Fill Volume per syringe, packaged in 10-count syringes per heat sealed bag, RX only; Compounded for Office Use by SCA Pharmaceuticals, Little Rock, AR (877 ) 550-5059 Bar Code 88888-7720-16 | Presence of particulate. | SCA Pharmaceuticals / 421 syringes | Class II | Terminated |
| D-0399-2015 | 02-23-2015 | Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only, 10 mL Multi-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-672-10 | Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility. | Sagent Pharmaceuticals Inc / 140,850 vials | Class II | Terminated |
| D-0411-2015 | 02-23-2015 | PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan Hydrobromide, USP), EACH 5 ml (ONE TEASPOONFUL) CONTAINS: Promethazine Hydrochloride 6.25 mg, Dextromethorphan Hydrobromide 15 mg, alcohol 7%, ONE PINT (574 mL), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-1586-58. | Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product. | Qualitest Pharmaceuticals / 972 bottles | Class II | Terminated |
| D-0398-2015 | 02-23-2015 | Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-659-05 | Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility. | Sagent Pharmaceuticals Inc / 140,720 vials | Class II | Terminated |
| D-0484-2015 | 02-18-2015 | KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by RemedyRepack, Indiana, PA, mfg by Hospira, Inc. Lake Forest, IL NDC 61786-0055-01 | Crystallization | RemedyRepack Inc. / 25 vials | Class II | Terminated |
| D-0421-2015 | 02-18-2015 | Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) packaged in cartons of five (NDC 67457-409-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103 Package NDCs: 67457-410-00; 67457-410-13; 67457-409-00; 67457-409-13 | Lack of Assurance of Sterility; due to leaking vials | Mylan Institutional LLC / 11,030 cartons (55,150 vials) | Class II | Terminated |
| D-0422-2015 | 02-18-2015 | Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of ten (NDC 67457-410-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103 Package NDCs: 67457-410-00; 67457-410-13; 67457-409-00; 67457-409-13 | Lack of Assurance of Sterility; due to leaking vials | Mylan Institutional LLC / 2,523 cartons (25,936 vials) | Class II | Terminated |
| D-0420-2015 | 02-16-2015 | Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials, For Intravenous or Intramuscular Use, Preservative Free, Rx Only, Manufactured by: West-Ward Pharmaceuticals, Eatontown, NJ 07724, NDC 0641-6028-25. Package NDCs: 0641-6024-01; 0641-6024-10; 0641-6027-01; 0641-6027-25; 0641-6025-01; 0641-6025-10; 0641-6028-01; 0641-6028-10; 0641-6028-25; 0641-6026-01; 0641-6026-05; 0641-6029-01; 0641-6029-25; 0641-6030-01; 0641-6247-01; 0641-6247-25; 0641-6248-01; 0641-6248-10; 0641-6249-01; 0641-6249-10 | Failed Impurities/Degradation Specifications; 12 month stability testing. | West-Ward Pharmaceutical Corporation / 445,475 Vials | Class III | Terminated |
| D-0397-2015 | 02-13-2015 | AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 | Failed tablet specifications: One lot was found to contain oversized tablets. | Qualitest Pharmaceuticals / 2808 bottles | Class II | Terminated |
| D-1057-2015 | 02-12-2015 | Colchicine 0.6 mg Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance. | Health Innovations Pharmacy, Inc / N/A | Class II | Terminated |
| D-1002-2015 | 02-12-2015 | Sodium Tetradecyl 1% Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance. | Health Innovations Pharmacy, Inc / N/A | Class II | Terminated |
| D-1016-2015 | 02-12-2015 | Ibuprofen 10% cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance. | Health Innovations Pharmacy, Inc / N/A | Class II | Terminated |
| D-1046-2015 | 02-12-2015 | Renacidin Irrigation Solution, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance. | Health Innovations Pharmacy, Inc / N/A | Class II | Terminated |
| D-1033-2015 | 02-12-2015 | Pyrimethamine 2 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance. | Health Innovations Pharmacy, Inc / N/A | Class II | Terminated |
| D-1000-2015 | 02-12-2015 | Cyanocobalamin 2000mcg/1ml Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance. | Health Innovations Pharmacy, Inc / N/A | Class II | Terminated |
| D-1059-2015 | 02-12-2015 | Cyclandelate 200 mg Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance. | Health Innovations Pharmacy, Inc / N/A | Class II | Terminated |
| D-1030-2015 | 02-12-2015 | Nitroglycerin 0.2% Compd Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance. | Health Innovations Pharmacy, Inc / N/A | Class II | Terminated |
| D-1035-2015 | 02-12-2015 | Nadolol 10 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance. | Health Innovations Pharmacy, Inc / N/A | Class II | Terminated |
| D-1062-2015 | 02-12-2015 | Hydrocortisone 1.6 mg/0.5 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance. | Health Innovations Pharmacy, Inc / N/A | Class II | Terminated |
| D-1044-2015 | 02-12-2015 | Pyridoxine 100 mg/1 mL Syrup, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance. | Health Innovations Pharmacy, Inc / N/A | Class II | Terminated |
| D-0998-2015 | 02-12-2015 | 17-HP Hydroxyprogesterone 250mg/1ml Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance. | Health Innovations Pharmacy, Inc / N/A | Class II | Terminated |
