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-0785-2018 | 04-03-2018 | Cyclophosphamide 50 mg cap NDC 00054-0383-25 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0744-2018 | 04-03-2018 | Cayston 75 mg Inh. Soln. SDV NDC 61958-0901-01 56 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0794-2018 | 04-03-2018 | Letrozole 2.5 mg tab NDC 51991-0759-33 30 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0792-2018 | 04-03-2018 | Bendeka 25 mg/mL 4 mL MDVPF NDC 63459-0348-04 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0752-2018 | 04-03-2018 | Bethkis 300 mg/4 mL Ampule #56 NDC 10122-0820-56 56 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0791-2018 | 04-03-2018 | Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0756-2018 | 04-03-2018 | MVW Complete Softgels NDC 58204-0004-00 30 days supply; MVW Complete Chew Vitamin Grape NDC 58204-0004-15 30 days supply. | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / N/A | Class II | Terminated |
| D-0765-2018 | 04-03-2018 | Copaxone 40 mg Injection (12) NDC 68546-0325-12 28 days supply. | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0796-2018 | 04-03-2018 | Zarxio 300 mcg/0.5 mL PFS NDC 14 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0740-2018 | 04-03-2018 | Otezla 30 mg tablet NDC 59572-0631-06 30 days supply; | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0736-2018 | 04-03-2018 | Kalydeco 150 mg tablet blister, 28 days supply, Rx Only, 39183, NDC 51167-0200-01 | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0758-2018 | 04-03-2018 | Xolair 150 mg SDV NDC 50242-0040-62 28 days | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0745-2018 | 04-03-2018 | Repatha 140 mg/mL Sureclick AI 2-pk NDC 55513-0760-02 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0786-2018 | 04-03-2018 | Dexamethasone 4 mg tablet NDC 49884-0087-01 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0766-2018 | 04-03-2018 | Copaxone 20 mg Injection PFS (30) NDC 68546-0317-30 30 days supply. | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0774-2018 | 04-03-2018 | Revlimid 5 mg oral cap NDC 59572-0405-28 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0790-2018 | 04-03-2018 | Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0793-2018 | 04-03-2018 | Ondansetron 8 mg tablet NDC 57237-0076-30 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0760-2018 | 04-03-2018 | Dupixent 300 mg/2 mL PFS #2 w/ NS NDC 00024-5914-01 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0781-2018 | 04-03-2018 | Temozolomide 250 mg NDC 43975-0257-05 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0800-2018 | 04-03-2018 | Lupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0798-2018 | 04-03-2018 | OPDIVO 40 mg/4 mL SDV NDC 00003-3772-11 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0739-2018 | 04-03-2018 | Pulmicort Respules 0.5 mg/2mL s, 30 days supply, NDC 00186-1989-04 | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0787-2018 | 04-03-2018 | Sutent 37.5 mg capsules x28 NDC 00069-0830-38 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0783-2018 | 04-03-2018 | Sprycel 80 mg tablet NDC 00003-0855-22 30 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0764-2018 | 04-03-2018 | Praluent 75 mg Pen (2 pens/Pkg) NDC 00024-5901-02 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0767-2018 | 04-03-2018 | Tecfidera 240 mg capsule NDC 64406-0006-02 30 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0738-2018 | 04-03-2018 | Polyethylene Glycol 3350, powder, for solution 527g BRE, Rx Only, 28 days supply, NDC 51991-0457-57 | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0751-2018 | 04-03-2018 | Orkambi 100 mg/125 mg Tablets #112 NDC 51167-0700-02 28 days supply. | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0784-2018 | 04-03-2018 | Sprycel 100 mg tablet NDC 00003-0852-22 30 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0749-2018 | 04-03-2018 | Kitabis Pak 300 mg/5 mL Soln PARI #56 NDC 24492-0850-56 56 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0788-2018 | 04-03-2018 | Sutent 50 mg capsules x28 NDC 00069-0550-38 42 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0799-2018 | 04-03-2018 | Kisqali 600 Dose 63 tablet 200 mg NDC 00078-0874-63 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0771-2018 | 04-03-2018 | Revlimid 10 mg oral cap NDC 59572-0410-28 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0768-2018 | 04-03-2018 | Pomalyst 3 mg capsule NDC 59572-0503-21 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0761-2018 | 04-03-2018 | Boost VHC Oral Liquid VAN #27 NDC 43900-0182-15 27 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0741-2018 | 04-03-2018 | Taltz 80 mg/mL Pen 1-pk NDC 00002-1445-11 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0769-2018 | 04-03-2018 | Xtandi 40 mg capsule NDC 00469-0125-99 30 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0737-2018 | 04-03-2018 | Pediasure Liq. Vanilla G+G (CAN) #24 24 days supply, NDC 70074-0558-98 | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0773-2018 | 04-03-2018 | Revlimid 20 mg oral cap NDC 59572-0420-21 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0789-2018 | 04-03-2018 | Imatinib Mesylate Tablet 400 mg NDC 60505-2901-03 30 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0735-2018 | 04-03-2018 | Albuterol 0.083% Inh Sol. 30 days supply, Rx Only, 39183, NDC 76204-0200-60, 30 | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0747-2018 | 04-03-2018 | Botox 100 Units Vial NDC 00023-1145-01 90 days supply. | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0776-2018 | 04-03-2018 | Avonex 30 mcg/0.5 mL PFS Kit NDC 59627-0222-05 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0742-2018 | 04-03-2018 | Cosentyx 150 mg/mL PFS 300 mg Dose NDC 00078-0639-98, 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0743-2018 | 04-03-2018 | Altera Handset NDC 83490-0678-05 56 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0734-2018 | 04-03-2018 | Humira Pen Sub-q Kit a.) 40 mg/0.8 mL (NDC 00074-4339-02); Humira Pen Psor Kit b.) 40 mg/0.8 mL (NDC 00074-4339-07) 28 day supply, Rx Only, | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0754-2018 | 04-03-2018 | Azithromycin 250 mg tablet #18 TEV NDC 50111-0787-66 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0753-2018 | 04-03-2018 | Pulmozyme 1 mg/mL Inh. Soln. #30 NDC 50242-0100-40 30 days supply. | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0782-2018 | 04-03-2018 | Gleevec 100 mg tablet NDC 00078-0401-34 30 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0775-2018 | 04-03-2018 | Revlimid 25 mg oral cap NDC 59572-0425-21 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0746-2018 | 04-03-2018 | Enbrel PFS 50 mg/mL Inj #4 NDC 58406-0435-04 28 days supply; | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0750-2018 | 04-03-2018 | Orkambi 200 mg/125 mg Tablets #112 NDC 51167-0809-01 28 days supply. | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0795-2018 | 04-03-2018 | Perjeta 420 mg/14 mL SDV Vials 50242-0145-01 21 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0772-2018 | 04-03-2018 | Revlimid 15 mg oral cap NDC 59572-0415-21 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0777-2018 | 04-03-2018 | Ibrance 125 mg cap NDC 00069-0189-21 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0757-2018 | 04-03-2018 | Sodium Chloride 3% Inh. 4 mL NEP #30 NDC 00487-9003-60 30 days supply. | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0762-2018 | 04-03-2018 | Stelara 90 mg/MI PFS NDC 57894-0061-03 84 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0778-2018 | 04-03-2018 | Glatiramer Acetate 40 mg/mL NDC 00378-6961-12 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0759-2018 | 04-03-2018 | Vosevi 400/100/100 mg Tablets #28 NDC 61958-2401-01 28 days supply. | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0797-2018 | 04-03-2018 | Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0763-2018 | 04-03-2018 | Cimzia 200 mg/mL PFS Kit #2 NDC 50474-0710-79 28 days supply. | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0748-2018 | 04-03-2018 | Prolia 60 mg/1 mL PF syringe NDC 55513-0710-01 180 days supply. | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0779-2018 | 04-03-2018 | Xalkori 250 mg cap NDC 00069-8140-20 30 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0629-2018 | 04-02-2018 | ACURE, clarifying acne, glycolic + zinc (salicyclic acid 0.5%) towelettes, 30-count pouch, Distributed by Better Planet Brands, Fort Lauderdale, FL 33316, UPC 8 54049 00358 0. | CGMP Deviations: finished products were manufactured with poor quality water. | Diamond Wipes International, Inc. / 51,840 pouches | Class II | Terminated |
| D-0630-2018 | 04-02-2018 | WipeEssentials Wet Wipes (benzalkonium chloride 0.13%), 30-count pouches, Dist. by Diamond Wipes Int'l, Inc., Chino, CA 91710, UPC 7 66670 03988 6. | CGMP Deviations: finished products were manufactured with poor quality water. | Diamond Wipes International, Inc. / 5,148,792 pouches | Class II | Terminated |
| D-0628-2018 | 03-30-2018 | PASTA DE LASSAR ANDROMACO Skin Protection, 25% zinc oxide Topical cream, 60 gram tube, UPC #851357003004, NDC #75940-111-60 | Microbial Contamination of Non-Sterile Products | Marcas Usa Llc / 69,238 60 oz. tubes | Class II | Terminated |
| D-0633-2018 | 03-30-2018 | Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-069-15 Package NDCs: 50268-069-11; 50268-069-15 | Failed Dissolution Specifications | AVKARE Inc. / 2135 cartons | Class II | Terminated |
| D-0624-2018 | 03-29-2018 | Zhong Hua Jiu (menthol 1%) Patch, Distributed by United Pacific Company, UPC 6 924938 100226, NDC 53614-001-02 | CGMP Deviations: the product was produced with substandard GMP manufacturing processes. | United Pacific Co Ltd / 15,190 boxes | Class II | Terminated |
| D-0611-2018 | 03-29-2018 | Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (NDC 50383-720-18 or 50383-720-19), Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701. | Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay. | Akorn, Inc. / 56,1800 unit dose cups | Class III | Terminated |
| D-0612-2018 | 03-29-2018 | 24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, Inc., 5405 Windward Parkway, Alpharetta, GA 30004; Distributed in the USA by Halyard Sales, LLC, Alpharetta, GA 30004, Product 97012. | Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay. | Akorn, Inc. / 48,176 unit dose cups | Class III | Terminated |
| D-0613-2018 | 03-29-2018 | 24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, Inc., 5405 Windward Parkway, Alpharetta, GA 30004; Distributed in the USA by Halyard Sales, LLC, Alpharetta, GA 30004, Product 97014. | Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay. | Akorn, Inc. / 20,587 unit dose cups | Class III | Terminated |
| D-0621-2018 | 03-28-2018 | Conzerol zero molluscum contagiosum, Topical Cream, Net weight 0.78 (22g), Elrose Labs, Sanford Fl 32771 USA --- NDC 70223-001-06 | cGMP Deviations | Elroselabs Inc. / Unknown | Class II | Terminated |
| D-0622-2018 | 03-28-2018 | Molleave, 2 oz bottle, OTC, Manufactured for Elrose Labs, Inc. | cGMP Deviations | Elroselabs Inc. / Unknown | Class II | Terminated |
| D-0623-2018 | 03-28-2018 | Conzerol (antipoxin) H2O2 Gel, Hydrogen Peroxide Gel 3%, 1.5 oz. tube, OTC, Manufactured for Elrose Labs, Inc., Sanford, FL | cGMP Deviations | Elroselabs Inc. / Unknown | Class II | Terminated |
| D-0684-2018 | 03-27-2018 | Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL in (a) 60 mL packs ( NDC 68180-723-20) and (b) 100 mL packs ( 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 Package NDCs: 68180-722-20; 68180-722-10; 68180-722-04; 68180-722-05; 68180-723-20; 68180-723-10; 68180-723-04; 68180-723-05 | Superpotent Drug | Lupin Pharmaceuticals Inc. / 40,824 bottles | Class II | Terminated |
| D-0704-2018 | 03-27-2018 | Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for: AuroMedics Pharma, LLC, NDC 55150-243-46. Package NDCs: 55150-243-46; 55150-244-47; 55150-245-52 | Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap | AuroMedics Pharma LLC / 46824 bags | Class II | Terminated |
| D-0703-2018 | 03-27-2018 | Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-242-51 Package NDCs: 55150-242-51 | Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap | AuroMedics Pharma LLC / 395150 bags | Class II | Terminated |
| D-0706-2018 | 03-27-2018 | Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-247-47. Package NDCs: 55150-246-47; 55150-247-47; 55150-248-47 | Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap | AuroMedics Pharma LLC / 188941 bags | Class II | Terminated |
| D-0705-2018 | 03-27-2018 | Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-246-47. Package NDCs: 55150-246-47; 55150-247-47; 55150-248-47 | Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap | AuroMedics Pharma LLC / 261250 bags | Class II | Terminated |
| D-0707-2018 | 03-27-2018 | Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-248-47. Package NDCs: 55150-246-47; 55150-247-47; 55150-248-47 | Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap | AuroMedics Pharma LLC / 67300 bags | Class II | Terminated |
| D-0709-2018 | 03-27-2018 | Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-245-52 Package NDCs: 55150-243-46; 55150-244-47; 55150-245-52 | Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap | AuroMedics Pharma LLC / 308112 bags | Class II | Terminated |
| D-0708-2018 | 03-27-2018 | Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-244-47 Package NDCs: 55150-243-46; 55150-244-47; 55150-245-52 | Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap | AuroMedics Pharma LLC / 308472 bags | Class II | Terminated |
| D-0677-2018 | 03-22-2018 | Estradiol 25 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0643-2018 | 03-22-2018 | Nandrolone decanoate 200mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / 2 vials | Class II | Terminated |
| D-0655-2018 | 03-22-2018 | Methylcobalamin 12.5 mg/mL, Injectable Liquid, packaged in a) 5 mL amber vial, and b) 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0647-2018 | 03-22-2018 | Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / 1 vial | Class II | Terminated |
| D-0668-2018 | 03-22-2018 | Testosterone 55 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0646-2018 | 03-22-2018 | Vitamin D 50,000 unit/ml, 5 mL amber vial, Injectable Liquid, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. # 101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / 4 vials | Class II | Terminated |
| D-0676-2018 | 03-22-2018 | Estradiol 20 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0680-2018 | 03-22-2018 | Estradiol 50 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0667-2018 | 03-22-2018 | Testosterone 50 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0654-2018 | 03-22-2018 | Testosterone/Finasteride/Anastrozole 120 mg/10 mg/4 mg pellet Amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / one vial | Class II | Terminated |
| D-0652-2018 | 03-22-2018 | Testosterone/Estradiol 60 mg/6 mg pellet Amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 Testosterone/Finasteride 60 mg/5 mg pellet Amber vial, twist top surrounded by a wrapper Testosterone/Finasteride 80mg/8mg pellet Amber vial, twist top surrounded by a wrapper Testosterone/Finasteride/Anastrozole 120 mg/10 mg/4 mg pellet Amber vial, twist top surrounded by a wrapper | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / 1 vial | Class II | Terminated |
| D-0635-2018 | 03-22-2018 | B-complex (B1-200mg, B2-4mg, B3-200mg,B5-4mg,B6-4mg) /mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / 5 vials | Class II | Terminated |
| D-0637-2018 | 03-22-2018 | CoEnzymeQ10 25mg/mL, 5mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / 3 vials | Class II | Terminated |
| D-0657-2018 | 03-22-2018 | Testosterone Propionate 100mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0681-2018 | 03-22-2018 | Estradiol 55 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0672-2018 | 03-22-2018 | Testosterone/Anastrozole 60 mg/4 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0634-2018 | 03-22-2018 | Ascorbic Acid (Tapioca) 500 mg/mL, 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / 4 vials | Class II | Terminated |
