Zarxio 300 mcg/0.5 mL PFS NDC 14 days supply

FDA recall notice · announced May 16, 2018 · Kroger Specialty Pharmacy

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

Lack of Processing Controls.

Notes

Distribution: MS, LA, AR, IL, FL
Lot/code information: All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Quantity: Unknown
Status: Terminated
Products in this recall event:
- Gleevec 100 mg tablet NDC 00078-0401-34 30 days supply (D-0782-2018)
- Orkambi 100 mg/125 mg Tablets #112 NDC 51167-0700-02 28 days supply. (D-0751-2018)
- Copaxone 20 mg Injection PFS (30) NDC 68546-0317-30 30 days supply. (D-0766-2018)
- Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply (D-0797-2018)
- 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, (D-0734-2018)
- Taltz 80 mg/mL Pen 1-pk NDC 00002-1445-11 28 days supply (D-0741-2018)
- Bendeka 25 mg/mL 4 mL MDVPF NDC 63459-0348-04 28 days supply (D-0792-2018)
- Otezla 30 mg tablet NDC 59572-0631-06 30 days supply; (D-0740-2018)
- Altera Handset NDC 83490-0678-05 56 days supply (D-0743-2018)
- Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply (D-0791-2018)
- Kalydeco 150 mg tablet blister, 28 days supply, Rx Only, 39183, NDC 51167-0200-01 (D-0736-2018)
- Cimzia 200 mg/mL PFS Kit #2 NDC 50474-0710-79 28 days supply. (D-0763-2018)
- Sutent 50 mg capsules x28 NDC 00069-0550-38 42 days supply (D-0788-2018)
- Azithromycin 250 mg tablet #18 TEV NDC 50111-0787-66 28 days supply (D-0754-2018)
- Xolair 150 mg SDV NDC 50242-0040-62 28 days (D-0758-2018)
- Boost VHC Oral Liquid VAN #27 NDC 43900-0182-15 27 days supply (D-0761-2018)
- Bethkis 300 mg/4 mL Ampule #56 NDC 10122-0820-56 56 days supply (D-0752-2018)
- Dexamethasone 4 mg tablet NDC 49884-0087-01 28 days supply (D-0786-2018)
- Perjeta 420 mg/14 mL SDV Vials 50242-0145-01 21 days supply (D-0795-2018)
- Xtandi 40 mg capsule NDC 00469-0125-99 30 days supply (D-0769-2018)
- Sprycel 80 mg tablet NDC 00003-0855-22 30 days supply (D-0783-2018)
- Pulmicort Respules 0.5 mg/2mL s, 30 days supply, NDC 00186-1989-04 (D-0739-2018)
- Pulmozyme 1 mg/mL Inh. Soln. #30 NDC 50242-0100-40 30 days supply. (D-0753-2018)
- MVW Complete Softgels NDC 58204-0004-00 30 days supply; MVW Complete Chew Vitamin Grape NDC 58204-0004-15 30 days supply. (D-0756-2018)
- Botox 100 Units Vial NDC 00023-1145-01 90 days supply. (D-0747-2018)
- Glatiramer Acetate 40 mg/mL NDC 00378-6961-12 28 days supply (D-0778-2018)
- Repatha 140 mg/mL Sureclick AI 2-pk NDC 55513-0760-02 28 days supply (D-0745-2018)
- Copaxone 40 mg Injection (12) NDC 68546-0325-12 28 days supply. (D-0765-2018)
- Sutent 37.5 mg capsules x28 NDC 00069-0830-38 28 days supply (D-0787-2018)
- OPDIVO 40 mg/4 mL SDV NDC 00003-3772-11 28 days supply (D-0798-2018)
- Sodium Chloride 3% Inh. 4 mL NEP #30 NDC 00487-9003-60 30 days supply. (D-0757-2018)
- Vosevi 400/100/100 mg Tablets #28 NDC 61958-2401-01 28 days supply. (D-0759-2018)
- Stelara 90 mg/MI PFS NDC 57894-0061-03 84 days supply (D-0762-2018)
- Pomalyst 3 mg capsule NDC 59572-0503-21 28 days supply (D-0768-2018)
- Cyclophosphamide 50 mg cap NDC 00054-0383-25 28 days supply (D-0785-2018)
- Lupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply (D-0800-2018)
- Cayston 75 mg Inh. Soln. SDV NDC 61958-0901-01 56 days supply (D-0744-2018)
- Revlimid 20 mg oral cap NDC 59572-0420-21 28 days supply (D-0773-2018)
- Ibrance 125 mg cap NDC 00069-0189-21 28 days supply (D-0777-2018)
- Imatinib Mesylate Tablet 400 mg NDC 60505-2901-03 30 days supply (D-0789-2018)
- Sprycel 100 mg tablet NDC 00003-0852-22 30 days supply (D-0784-2018)
- Revlimid 10 mg oral cap NDC 59572-0410-28 28 days supply (D-0771-2018)
- Kitabis Pak 300 mg/5 mL Soln PARI #56 NDC 24492-0850-56 56 days supply (D-0749-2018)
- Orkambi 200 mg/125 mg Tablets #112 NDC 51167-0809-01 28 days supply. (D-0750-2018)
- Revlimid 15 mg oral cap NDC 59572-0415-21 28 days supply (D-0772-2018)
- Temozolomide 250 mg NDC 43975-0257-05 28 days supply (D-0781-2018)
- Ondansetron 8 mg tablet NDC 57237-0076-30 28 days supply (D-0793-2018)
- Promacta 50 mg tablet NDC 00078-0686-15 30 days supply (D-0770-2018)
- Polyethylene Glycol 3350, powder, for solution 527g BRE, Rx Only, 28 days supply, NDC 51991-0457-57 (D-0738-2018)
- Avonex 30 mcg/0.5 mL PFS Kit NDC 59627-0222-05 28 days supply (D-0776-2018)
- Kisqali 600 Dose 63 tablet 200 mg NDC 00078-0874-63 28 days supply (D-0799-2018)
- Prolia 60 mg/1 mL PF syringe NDC 55513-0710-01 180 days supply. (D-0748-2018)
- Cosentyx 150 mg/mL PFS 300 mg Dose NDC 00078-0639-98, 28 days supply (D-0742-2018)
- Albuterol 0.083% Inh Sol. 30 days supply, Rx Only, 39183, NDC 76204-0200-60, 30 (D-0735-2018)
- Dupixent 300 mg/2 mL PFS #2 w/ NS NDC 00024-5914-01 28 days supply (D-0760-2018)
- Creon DR 24,000 Units Capsule #250 NDC 00032-1224-07 30 days supply (D-0755-2018)
- Revlimid 25 mg oral cap NDC 59572-0425-21 28 days supply (D-0775-2018)
- Enbrel PFS 50 mg/mL Inj #4 NDC 58406-0435-04 28 days supply; (D-0746-2018)
- Praluent 75 mg Pen (2 pens/Pkg) NDC 00024-5901-02 28 days supply (D-0764-2018)
- Revlimid 5 mg oral cap NDC 59572-0405-28 28 days supply (D-0774-2018)
- Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply (D-0790-2018)
- Letrozole 2.5 mg tab NDC 51991-0759-33 30 days supply (D-0794-2018)
- Xalkori 250 mg cap NDC 00069-8140-20 30 days supply (D-0779-2018)
- Tecfidera 240 mg capsule NDC 64406-0006-02 30 days supply (D-0767-2018)
- Temozolomide 20 mg NDC 43975-0253-05 28 days supply (D-0780-2018)
- Pediasure Liq. Vanilla G+G (CAN) #24 24 days supply, NDC 70074-0558-98 (D-0737-2018)
- Zarxio 300 mcg/0.5 mL PFS NDC 14 days supply (D-0796-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.