Drug recall: 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…

Class II FDA enforcement event 79748. Recall start date: 3 Apr 2018. Status in the FDA record: Terminated. Termination date: 7 May 2020.

Reason for recall, in the words of FDA

Lack of Processing Controls.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Kroger Specialty Pharmacy, Inc. started this drug recall on 3 Apr 2018. The firm address in the FDA record is in Vicksburg, MS. FDA put the recall in Class II. FDA event 79748 has 67 product records. The first FDA enforcement report date is 16 May 2018. The record gives the status Terminated, with the termination date 7 May 2020.

FDA enforcement report The 67 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

MS, LA, AR, IL, FL

Recalling firm

Kroger Specialty Pharmacy, Inc., Vicksburg, MS.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

67 product records in the event.

FDA event 79748: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0734-2018	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,	Unknown	Class II	Terminated	16 May 2018
D-0735-2018	Albuterol 0.083% Inh Sol. 30 days supply, Rx Only, 39183, NDC 76204-0200-60, 30	Unknown	Class II	Terminated	16 May 2018
D-0736-2018	Kalydeco 150 mg tablet blister, 28 days supply, Rx Only, 39183, NDC 51167-0200-01	Unknown	Class II	Terminated	16 May 2018
D-0737-2018	Pediasure Liq. Vanilla G+G (CAN) #24 24 days supply, NDC 70074-0558-98	Unknown	Class II	Terminated	16 May 2018
D-0738-2018	Polyethylene Glycol 3350, powder, for solution 527g BRE, Rx Only, 28 days supply, NDC 51991-0457-57	Unknown	Class II	Terminated	16 May 2018
D-0739-2018	Pulmicort Respules 0.5 mg/2mL s, 30 days supply, NDC 00186-1989-04	Unknown	Class II	Terminated	16 May 2018
D-0740-2018	Otezla 30 mg tablet NDC 59572-0631-06 30 days supply;	Unknown	Class II	Terminated	16 May 2018
D-0741-2018	Taltz 80 mg/mL Pen 1-pk NDC 00002-1445-11 28 days supply	Unknown	Class II	Terminated	16 May 2018
D-0742-2018	Cosentyx 150 mg/mL PFS 300 mg Dose NDC 00078-0639-98, 28 days supply	Unknown	Class II	Terminated	16 May 2018
D-0743-2018	Altera Handset NDC 83490-0678-05 56 days supply	Unknown	Class II	Terminated	16 May 2018
D-0744-2018	Cayston 75 mg Inh. Soln. SDV NDC 61958-0901-01 56 days supply	Unknown	Class II	Terminated	16 May 2018
D-0745-2018	Repatha 140 mg/mL Sureclick AI 2-pk NDC 55513-0760-02 28 days supply	Unknown	Class II	Terminated	16 May 2018
D-0746-2018	Enbrel PFS 50 mg/mL Inj #4 NDC 58406-0435-04 28 days supply;	Unknown	Class II	Terminated	16 May 2018
D-0747-2018	Botox 100 Units Vial NDC 00023-1145-01 90 days supply.	Unknown	Class II	Terminated	16 May 2018
D-0748-2018	Prolia 60 mg/1 mL PF syringe NDC 55513-0710-01 180 days supply.	Unknown	Class II	Terminated	16 May 2018
D-0749-2018	Kitabis Pak 300 mg/5 mL Soln PARI #56 NDC 24492-0850-56 56 days supply	Unknown	Class II	Terminated	16 May 2018
D-0750-2018	Orkambi 200 mg/125 mg Tablets #112 NDC 51167-0809-01 28 days supply.	Unknown	Class II	Terminated	16 May 2018
D-0751-2018	Orkambi 100 mg/125 mg Tablets #112 NDC 51167-0700-02 28 days supply.	Unknown	Class II	Terminated	16 May 2018
D-0752-2018	Bethkis 300 mg/4 mL Ampule #56 NDC 10122-0820-56 56 days supply	Unknown	Class II	Terminated	16 May 2018
D-0753-2018	Pulmozyme 1 mg/mL Inh. Soln. #30 NDC 50242-0100-40 30 days supply.	Unknown	Class II	Terminated	16 May 2018
D-0754-2018	Azithromycin 250 mg tablet #18 TEV NDC 50111-0787-66 28 days supply	Unknown	Class II	Terminated	16 May 2018
D-0755-2018	Creon DR 24,000 Units Capsule #250 NDC 00032-1224-07 30 days supply	Unknown	Class II	Terminated	16 May 2018
D-0756-2018	MVW Complete Softgels NDC 58204-0004-00 30 days supply; MVW Complete Chew Vitamin Grape NDC 58204-0004-15 30 days supply.	N/A	Class II	Terminated	16 May 2018
D-0757-2018	Sodium Chloride 3% Inh. 4 mL NEP #30 NDC 00487-9003-60 30 days supply.	Unknown	Class II	Terminated	16 May 2018
D-0758-2018	Xolair 150 mg SDV NDC 50242-0040-62 28 days	Unknown	Class II	Terminated	16 May 2018
D-0759-2018	Vosevi 400/100/100 mg Tablets #28 NDC 61958-2401-01 28 days supply.	Unknown	Class II	Terminated	16 May 2018
D-0760-2018	Dupixent 300 mg/2 mL PFS #2 w/ NS NDC 00024-5914-01 28 days supply	Unknown	Class II	Terminated	16 May 2018
D-0761-2018	Boost VHC Oral Liquid VAN #27 NDC 43900-0182-15 27 days supply	Unknown	Class II	Terminated	16 May 2018
D-0762-2018	Stelara 90 mg/MI PFS NDC 57894-0061-03 84 days supply	Unknown	Class II	Terminated	16 May 2018
D-0763-2018	Cimzia 200 mg/mL PFS Kit #2 NDC 50474-0710-79 28 days supply.	Unknown	Class II	Terminated	16 May 2018
D-0764-2018	Praluent 75 mg Pen (2 pens/Pkg) NDC 00024-5901-02 28 days supply	Unknown	Class II	Terminated	16 May 2018
D-0765-2018	Copaxone 40 mg Injection (12) NDC 68546-0325-12 28 days supply.	Unknown	Class II	Terminated	16 May 2018
D-0766-2018	Copaxone 20 mg Injection PFS (30) NDC 68546-0317-30 30 days supply.	Unknown	Class II	Terminated	16 May 2018
D-0767-2018	Tecfidera 240 mg capsule NDC 64406-0006-02 30 days supply	Unknown	Class II	Terminated	16 May 2018
D-0768-2018	Pomalyst 3 mg capsule NDC 59572-0503-21 28 days supply	Unknown	Class II	Terminated	16 May 2018
D-0769-2018	Xtandi 40 mg capsule NDC 00469-0125-99 30 days supply	Unknown	Class II	Terminated	16 May 2018
D-0770-2018	Promacta 50 mg tablet NDC 00078-0686-15 30 days supply	Unknown	Class II	Terminated	16 May 2018
D-0771-2018	Revlimid 10 mg oral cap NDC 59572-0410-28 28 days supply	Unknown	Class II	Terminated	16 May 2018
D-0772-2018	Revlimid 15 mg oral cap NDC 59572-0415-21 28 days supply	Unknown	Class II	Terminated	16 May 2018
D-0773-2018	Revlimid 20 mg oral cap NDC 59572-0420-21 28 days supply	Unknown	Class II	Terminated	16 May 2018
D-0774-2018	Revlimid 5 mg oral cap NDC 59572-0405-28 28 days supply	Unknown	Class II	Terminated	16 May 2018
D-0775-2018	Revlimid 25 mg oral cap NDC 59572-0425-21 28 days supply	Unknown	Class II	Terminated	16 May 2018
D-0776-2018	Avonex 30 mcg/0.5 mL PFS Kit NDC 59627-0222-05 28 days supply	Unknown	Class II	Terminated	16 May 2018
D-0777-2018	Ibrance 125 mg cap NDC 00069-0189-21 28 days supply	Unknown	Class II	Terminated	16 May 2018
D-0778-2018	Glatiramer Acetate 40 mg/mL NDC 00378-6961-12 28 days supply	Unknown	Class II	Terminated	16 May 2018
D-0779-2018	Xalkori 250 mg cap NDC 00069-8140-20 30 days supply	Unknown	Class II	Terminated	16 May 2018
D-0780-2018	Temozolomide 20 mg NDC 43975-0253-05 28 days supply	Unknown	Class II	Terminated	16 May 2018
D-0781-2018	Temozolomide 250 mg NDC 43975-0257-05 28 days supply	Unknown	Class II	Terminated	16 May 2018
D-0782-2018	Gleevec 100 mg tablet NDC 00078-0401-34 30 days supply	Unknown	Class II	Terminated	16 May 2018
D-0783-2018	Sprycel 80 mg tablet NDC 00003-0855-22 30 days supply	Unknown	Class II	Terminated	16 May 2018
D-0784-2018	Sprycel 100 mg tablet NDC 00003-0852-22 30 days supply	Unknown	Class II	Terminated	16 May 2018
D-0785-2018	Cyclophosphamide 50 mg cap NDC 00054-0383-25 28 days supply	Unknown	Class II	Terminated	16 May 2018
D-0786-2018	Dexamethasone 4 mg tablet NDC 49884-0087-01 28 days supply	Unknown	Class II	Terminated	16 May 2018
D-0787-2018	Sutent 37.5 mg capsules x28 NDC 00069-0830-38 28 days supply	Unknown	Class II	Terminated	16 May 2018
D-0788-2018	Sutent 50 mg capsules x28 NDC 00069-0550-38 42 days supply	Unknown	Class II	Terminated	16 May 2018
D-0789-2018	Imatinib Mesylate Tablet 400 mg NDC 60505-2901-03 30 days supply	Unknown	Class II	Terminated	16 May 2018
D-0790-2018	Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply	Unknown	Class II	Terminated	16 May 2018
D-0791-2018	Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply	Unknown	Class II	Terminated	16 May 2018
D-0792-2018	Bendeka 25 mg/mL 4 mL MDVPF NDC 63459-0348-04 28 days supply	Unknown	Class II	Terminated	16 May 2018
D-0793-2018	Ondansetron 8 mg tablet NDC 57237-0076-30 28 days supply	Unknown	Class II	Terminated	16 May 2018

The table shows 60 of 67 product records. The FDA enforcement report lists all the records.

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2018: 367
Share of these events in Class II: 60%
Product records in this event: 67
Events of the firm on the register: 1

Official channels

FDA enforcement report D-0734-2018The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 79748. https://recallregister.com/fda/ii/79748/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: MS, LA, AR, IL, FL
What quantity of product is in FDA event 79748?: The event has 67 product records. The first record gives this quantity: Unknown
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2018 have the same class?: 60% of the 367 drug events that started in 2018 are in Class II.