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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Kroger Specialty Pharmacy, Inc.: Humira, Kalydeco, and Various Medications Recalled for Processing Control Errors

Agency Publication Date: May 10, 2018
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Summary

Kroger Specialty Pharmacy is recalling approximately 67 different prescription and specialty medications due to a lack of necessary processing controls during their handling. Affected medications include common treatments like Humira Pen Kits (adalimumab), Albuterol inhalation solution, and various specialty drugs dispensed between December 1, 2017, and February 12, 2018. Because proper protocols were not followed, the safety and quality of these medications cannot be guaranteed.

Risk

The lack of processing controls may result in compromised medication quality or safety, potentially leading to ineffective treatment or unexpected side effects for patients using these products. No specific injuries have been reported in the provided data, but the recall is classified as medium risk due to the nature of the specialty medications involved.

What You Should Do

  1. Check your medication packaging and pharmacy records to see if your prescription was dispensed by Kroger Specialty Pharmacy between December 1, 2017, and February 12, 2018.
  2. Identify your medication by checking the NDC numbers and product names, such as Humira Pen Kit (NDC 00074-4339-02), Kalydeco 150 mg (NDC 51167-0200-01), or any of the other 65 medications listed in this recall.
  3. Immediately contact your healthcare provider or pharmacist to discuss your treatment and determine if a replacement medication is necessary.
  4. Return any unused or remaining portions of the affected medications to the pharmacy where you received them for a refund.
  5. Contact Kroger Specialty Pharmacy at their Vicksburg, Mississippi location at 100 Pear Orchard Dr Ste A for further instructions regarding this recall.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Pharmacy refund for unused medication

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Humira Pen Sub-q Kit 40 mg/0.8 mL
Model:
NDC 00074-4339-02
D-0734-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Humira Pen Psor Kit 40 mg/0.8 mL
Model:
NDC 00074-4339-07
D-0734-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Albuterol 0.083% Inh Sol.
Model:
NDC 76204-0200-60
D-0735-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Kalydeco 150 mg tablet blister
Model:
NDC 51167-0200-01
D-0736-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Pediasure Liq. Vanilla G+G (CAN) #24
Model:
NDC 70074-0558-98
D-0737-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Polyethylene Glycol 3350, powder 527g BRE
Model:
NDC 51991-0457-57
D-0738-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Pulmicort Respules 0.5 mg/2mL
Model:
NDC 00186-1989-04
D-0739-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Otezla 30 mg tablet
Model:
NDC 59572-0631-06
D-0740-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Taltz 80 mg/mL Pen 1-pk
Model:
NDC 00002-1445-11
D-0741-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Cosentyx 150 mg/mL PFS 300 mg Dose
Model:
NDC 00078-0639-98
D-0742-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Altera Handset
Model:
NDC 83490-0678-05
D-0743-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Cayston 75 mg Inh. Soln. SDV
Model:
NDC 61958-0901-01
D-0744-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Repatha 140 mg/mL Sureclick AI 2-pk
Model:
NDC 55513-0760-02
D-0745-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Enbrel PFS 50 mg/mL Inj #4
Model:
NDC 58406-0435-04
D-0746-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Botox 100 Units Vial
Model:
NDC 00023-1145-01
D-0747-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Prolia 60 mg/1 mL PF syringe
Model:
NDC 55513-0710-01
D-0748-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Kitabis Pak 300 mg/5 mL Soln PARI #56
Model:
NDC 24492-0850-56
D-0749-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Orkambi 200 mg/125 mg Tablets #112
Model:
NDC 51167-0809-01
D-0750-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Orkambi 100 mg/125 mg Tablets #112
Model:
NDC 51167-0700-02
D-0751-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Bethkis 300 mg/4 mL Ampule #56
Model:
NDC 10122-0820-56
D-0752-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Pulmozyme 1 mg/mL Inh. Soln. #30
Model:
NDC 50242-0100-40
D-0753-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Azithromycin 250 mg tablet #18 TEV
Model:
NDC 50111-0787-66
D-0754-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Creon DR 24,000 Units Capsule #250
Model:
NDC 00032-1224-07
D-0755-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: MVW Complete Softgels
Model:
NDC 58204-0004-00
D-0756-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: MVW Complete Chew Vitamin Grape
Model:
NDC 58204-0004-15
D-0756-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Sodium Chloride 3% Inh. 4 mL NEP #30
Model:
NDC 00487-9003-60
D-0757-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Xolair 150 mg SDV
Model:
NDC 50242-0040-62
D-0758-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Vosevi 400/100/100 mg Tablets #28
Model:
NDC 61958-2401-01
D-0759-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Dupixent 300 mg/2 mL PFS #2 w/ NS
Model:
NDC 00024-5914-01
D-0760-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Boost VHC Oral Liquid VAN #27
Model:
NDC 43900-0182-15
D-0761-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Stelara 90 mg/MI PFS
Model:
NDC 57894-0061-03
D-0762-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Cimzia 200 mg/mL PFS Kit #2
Model:
NDC 50474-0710-79
D-0763-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Praluent 75 mg Pen (2 pens/Pkg)
Model:
NDC 00024-5901-02
D-0764-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Copaxone 40 mg Injection (12)
Model:
NDC 68546-0325-12
D-0765-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Copaxone 20 mg Injection PFS (30)
Model:
NDC 68546-0317-30
D-0766-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Tecfidera 240 mg capsule
Model:
NDC 64406-0006-02
D-0767-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Pomalyst 3 mg capsule
Model:
NDC 59572-0503-21
D-0768-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Xtandi 40 mg capsule
Model:
NDC 00469-0125-99
D-0769-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Promacta 50 mg tablet
Model:
NDC 00078-0686-15
D-0770-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Revlimid 10 mg oral cap
Model:
NDC 59572-0410-28
D-0771-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Revlimid 15 mg oral cap
Model:
NDC 59572-0415-21
D-0772-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Revlimid 20 mg oral cap
Model:
NDC 59572-0420-21
D-0773-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Revlimid 5 mg oral cap
Model:
NDC 59572-0405-28
D-0774-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Revlimid 25 mg oral cap
Model:
NDC 59572-0425-21
D-0775-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Avonex 30 mcg/0.5 mL PFS Kit
Model:
NDC 59627-0222-05
D-0776-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Ibrance 125 mg cap
Model:
NDC 00069-0189-21
D-0777-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Glatiramer Acetate 40 mg/mL
Model:
NDC 00378-6961-12
D-0778-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Xalkori 250 mg cap
Model:
NDC 00069-8140-20
D-0779-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Temozolomide 20 mg
Model:
NDC 43975-0253-05
D-0780-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Temozolomide 250 mg
Model:
NDC 43975-0257-05
D-0781-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Gleevec 100 mg tablet
Model:
NDC 00078-0401-34
D-0782-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Sprycel 80 mg tablet
Model:
NDC 00003-0855-22
D-0783-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Sprycel 100 mg tablet
Model:
NDC 00003-0852-22
D-0784-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Cyclophosphamide 50 mg cap
Model:
NDC 00054-0383-25
D-0785-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Dexamethasone 4 mg tablet
Model:
NDC 49884-0087-01
D-0786-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Sutent 37.5 mg capsules x28
Model:
NDC 00069-0830-38
D-0787-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Sutent 50 mg capsules x28
Model:
NDC 00069-0550-38
D-0788-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Imatinib Mesylate Tablet 400 mg
Model:
NDC 60505-2901-03
D-0789-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Capecitabine 150 mg Tablet
Model:
NDC 00378-2511-91
D-0790-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Capecitabine 500 mg Tablet
Model:
NDC 00378-2512-78
D-0791-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Bendeka 25 mg/mL 4 mL MDVPF
Model:
NDC 63459-0348-04
D-0792-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Ondansetron 8 mg tablet
Model:
NDC 57237-0076-30
D-0793-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Letrozole 2.5 mg tab
Model:
NDC 51991-0759-33
D-0794-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Perjeta 420 mg/14 mL SDV Vials
Model:
NDC 50242-0145-01
D-0795-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Zarxio 300 mcg/0.5 mL PFS
Model:
D-0796-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Tasigna Capsules 150 mg
Model:
NDC 00078-0592-87
D-0797-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: OPDIVO 40 mg/4 mL SDV
Model:
NDC 00003-3772-11
D-0798-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Kisqali 600 Dose 63 tablet 200 mg
Model:
NDC 00078-0874-63
D-0799-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018
Product: Lupron Depot 22.5 mg 3 month Kit
Model:
NDC 00074-3346-03
D-0800-2018
Lot Numbers:
All lots remaining within expiry
Date Ranges: Dispensed 12/01/2017 through 02/12/2018

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79748
Status: Resolved
Manufacturer: Kroger Specialty Pharmacy, Inc.
Sold By: Kroger Specialty Pharmacy
Manufactured In: United States
Units Affected: 66 products (Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown)
Distributed To: Mississippi, Louisiana, Arkansas, Illinois, Florida

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.