CLASS II Drug recall · Reported 16 May 2018 · FDA Enforcement Report

Kitabis Pak 300 mg/ Soln PARI #56 recalled by Kroger Specialty Pharmacy

Kroger Specialty Pharmacy is recalling Kitabis Pak 300 mg/ Soln PARI #56, distributed in Arkansas, Florida, Illinois, Louisiana, Mississippi. The recall was initiated on 3 Apr 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots remaining within expiry dispensed 12/01/2017 through 02/12/2018

Quantity recalledUnknown

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0749-2018
FDA event ID: 79748
Recalling firm: Kroger Specialty Pharmacy, Vicksburg, MS
Classification: Class II
Status: Terminated
Recall initiated: 3 Apr 2018
FDA classified: 10 May 2018
Reported: 16 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons

Timeline

3 Apr 2018	Recall initiated by company
10 May 2018	Classified by FDA	+37 days
16 May 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Processing Controls.

Product as listed by the FDA

Kitabis Pak 300 mg/5 mL Soln PARI #56 NDC 24492-0850-56 56 days supply

Where it was distributed

MS, LA, AR, IL, FL

Arkansas Florida Illinois Louisiana Mississippi

Stores named: Kroger

Questions about this recall

Why was it recalled?

Lack of Processing Controls.

Which lots are affected?

All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018

Where was it sold?

MS, LA, AR, IL, FL

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

66 other products · FDA event 79748

This product is part of a recall event; the main page for the event is Zarxio 300 mcg/ PFS recalled by Kroger Specialty Pharmacy.

Reported	Class	Recall	Company	Reason	Where
16 May 2018	CLASS II	Zarxio 300 mcg/ PFS recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Gleevec 100 mg tablet recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Orkambi 100 mg/ #112 recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Copaxone 20 mg Injection PFS recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Tasigna Capsules 150 mg recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Humira Pen Sub-q Kit a.) 40 mg recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Taltz 80 mg/mL Pen recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Bendeka 25 mg/mL Mdvpf recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Otezla 30 mg tablet recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Altera Handset recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Capecitabine 500 mg Tablet recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Kalydeco blister, 28 days supply recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Cimzia 200 mg/mL PFS Kit #2 recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Sutent x28 recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Azithromycin #18 TEV recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Xolair 150 mg SDV recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Boost VHC Oral Liquid VAN #27 recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Bethkis 300 mg/ Ampule #56 recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Dexamethasone 4 mg tablet recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Perjeta 420 mg/ SDV Vials 50242-0145-01 21 days supply recalled	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Xtandi 40 mg capsule recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Sprycel 80 mg tablet recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Pulmicort Respules 0.5 mg/ s, 30 days supply recalled	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Pulmozyme 1 mg/mL Inh recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	MVW Complete Softgels recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Botox 100 Units Vial recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Glatiramer Acetate 40 mg/mL recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Repatha 140 mg/mL Sureclick AI recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Copaxone 40 mg Injection recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Sutent 37. x28 recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Opdivo 40 mg/ SDV recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Sodium Chloride 3% Inh recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Vosevi 400/100/100 mg Tablets #28 recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Stelara 90 mg/MI PFS recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Pomalyst 3 mg capsule recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Cyclophosphamide 50 mg cap recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Lupron Depot 22.5 mg 3 month Kit recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Cayston 75 mg Inh recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Revlimid 20 mg oral cap recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Ibrance 125 mg cap recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Imatinib Mesylate Tablet 400 mg recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Sprycel 100 mg tablet recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Revlimid 10 mg oral cap recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Orkambi 200 mg/ #112 recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Revlimid 15 mg oral cap recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Temozolomide 250 mg recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Ondansetron 8 mg tablet recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Promacta 50 mg tablet recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Polyethylene Glycol 3350, powder, for solution BRE recalled	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Avonex 30 mcg/ PFS Kit recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Kisqali 600 Dose 200 mg recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Prolia 60 mg/ PF recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Cosentyx 150 mg/mL PFS 300 mg Dose recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Albuterol 0.083% Inh Sol recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Dupixent 300 mg/ PFS #2 w/ NS recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Creon DR Capsule #250 recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Revlimid 25 mg oral cap recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Enbrel PFS 50 mg/mL Inj #4 recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Praluent 75 mg Pen (2 pens/Pkg) recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Revlimid 5 mg oral cap recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Capecitabine 150 mg Tablet recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Letrozole 2.5 mg tab recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Xalkori 250 mg cap recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Tecfidera 240 mg capsule recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Temozolomide 20 mg recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018	CLASS II	Pediasure Liq recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states

More recalls from Kroger Specialty Pharmacy

All 67

Reported	Class	Recall	Company	Reason	Where
16 May 2018Drug	CLASS II	Pediasure Liq recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018Drug	CLASS II	Temozolomide 20 mg recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018Drug	CLASS II	Tecfidera 240 mg capsule recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018Drug	CLASS II	Xalkori 250 mg cap recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018Drug	CLASS II	Letrozole 2.5 mg tab recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states