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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79748

67 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 03, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Kroger Specialty Pharmacy, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

67 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 67

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
Recall number
D-0734-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 2 of 67

Albuterol 0.083% Inh Sol. 30 days supply, Rx Only, 39183, NDC 76204-0200-60, 30

D-0735-2018
Recall number
D-0735-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 3 of 67

Kalydeco 150 mg tablet blister, 28 days supply, Rx Only, 39183, NDC 51167-0200-01

D-0736-2018
Recall number
D-0736-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 4 of 67

Pediasure Liq. Vanilla G+G (CAN) #24 24 days supply, NDC 70074-0558-98

D-0737-2018
Recall number
D-0737-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 5 of 67

Polyethylene Glycol 3350, powder, for solution 527g BRE, Rx Only, 28 days supply, NDC 51991-0457-57

D-0738-2018
Recall number
D-0738-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 6 of 67

Pulmicort Respules 0.5 mg/2mL s, 30 days supply, NDC 00186-1989-04

D-0739-2018
Recall number
D-0739-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 7 of 67

Otezla 30 mg tablet NDC 59572-0631-06 30 days supply;

D-0740-2018
Recall number
D-0740-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 8 of 67

Taltz 80 mg/mL Pen 1-pk NDC 00002-1445-11 28 days supply

D-0741-2018
Recall number
D-0741-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 9 of 67

Cosentyx 150 mg/mL PFS 300 mg Dose NDC 00078-0639-98, 28 days supply

D-0742-2018
Recall number
D-0742-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 10 of 67

Altera Handset NDC 83490-0678-05 56 days supply

D-0743-2018
Recall number
D-0743-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 11 of 67

Cayston 75 mg Inh. Soln. SDV NDC 61958-0901-01 56 days supply

D-0744-2018
Recall number
D-0744-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 12 of 67

Repatha 140 mg/mL Sureclick AI 2-pk NDC 55513-0760-02 28 days supply

D-0745-2018
Recall number
D-0745-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 13 of 67

Enbrel PFS 50 mg/mL Inj #4 NDC 58406-0435-04 28 days supply;

D-0746-2018
Recall number
D-0746-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 14 of 67

Botox 100 Units Vial NDC 00023-1145-01 90 days supply.

D-0747-2018
Recall number
D-0747-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 15 of 67

Prolia 60 mg/1 mL PF syringe NDC 55513-0710-01 180 days supply.

D-0748-2018
Recall number
D-0748-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 16 of 67

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

D-0749-2018
Recall number
D-0749-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 17 of 67

Orkambi 200 mg/125 mg Tablets #112 NDC 51167-0809-01 28 days supply.

D-0750-2018
Recall number
D-0750-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 18 of 67

Orkambi 100 mg/125 mg Tablets #112 NDC 51167-0700-02 28 days supply.

D-0751-2018
Recall number
D-0751-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 19 of 67

Bethkis 300 mg/4 mL Ampule #56 NDC 10122-0820-56 56 days supply

D-0752-2018
Recall number
D-0752-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 20 of 67

Pulmozyme 1 mg/mL Inh. Soln. #30 NDC 50242-0100-40 30 days supply.

D-0753-2018
Recall number
D-0753-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 21 of 67

Azithromycin 250 mg tablet #18 TEV NDC 50111-0787-66 28 days supply

D-0754-2018
Recall number
D-0754-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 22 of 67

Creon DR 24,000 Units Capsule #250 NDC 00032-1224-07 30 days supply

D-0755-2018
Recall number
D-0755-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 23 of 67

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
Recall number
D-0756-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 24 of 67

Sodium Chloride 3% Inh. 4 mL NEP #30 NDC 00487-9003-60 30 days supply.

D-0757-2018
Recall number
D-0757-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 25 of 67

Xolair 150 mg SDV NDC 50242-0040-62 28 days

D-0758-2018
Recall number
D-0758-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 26 of 67

Vosevi 400/100/100 mg Tablets #28 NDC 61958-2401-01 28 days supply.

D-0759-2018
Recall number
D-0759-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 27 of 67

Dupixent 300 mg/2 mL PFS #2 w/ NS NDC 00024-5914-01 28 days supply

D-0760-2018
Recall number
D-0760-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 28 of 67

Boost VHC Oral Liquid VAN #27 NDC 43900-0182-15 27 days supply

D-0761-2018
Recall number
D-0761-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 29 of 67

Stelara 90 mg/MI PFS NDC 57894-0061-03 84 days supply

D-0762-2018
Recall number
D-0762-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 30 of 67

Cimzia 200 mg/mL PFS Kit #2 NDC 50474-0710-79 28 days supply.

D-0763-2018
Recall number
D-0763-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 31 of 67

Praluent 75 mg Pen (2 pens/Pkg) NDC 00024-5901-02 28 days supply

D-0764-2018
Recall number
D-0764-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 32 of 67

Copaxone 40 mg Injection (12) NDC 68546-0325-12 28 days supply.

D-0765-2018
Recall number
D-0765-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 33 of 67

Copaxone 20 mg Injection PFS (30) NDC 68546-0317-30 30 days supply.

D-0766-2018
Recall number
D-0766-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 34 of 67

Tecfidera 240 mg capsule NDC 64406-0006-02 30 days supply

D-0767-2018
Recall number
D-0767-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 35 of 67

Pomalyst 3 mg capsule NDC 59572-0503-21 28 days supply

D-0768-2018
Recall number
D-0768-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 36 of 67

Xtandi 40 mg capsule NDC 00469-0125-99 30 days supply

D-0769-2018
Recall number
D-0769-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 37 of 67

Promacta 50 mg tablet NDC 00078-0686-15 30 days supply

D-0770-2018
Recall number
D-0770-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 38 of 67

Revlimid 10 mg oral cap NDC 59572-0410-28 28 days supply

D-0771-2018
Recall number
D-0771-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 39 of 67

Revlimid 15 mg oral cap NDC 59572-0415-21 28 days supply

D-0772-2018
Recall number
D-0772-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 40 of 67

Revlimid 20 mg oral cap NDC 59572-0420-21 28 days supply

D-0773-2018
Recall number
D-0773-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 41 of 67

Revlimid 5 mg oral cap NDC 59572-0405-28 28 days supply

D-0774-2018
Recall number
D-0774-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 42 of 67

Revlimid 25 mg oral cap NDC 59572-0425-21 28 days supply

D-0775-2018
Recall number
D-0775-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 43 of 67

Avonex 30 mcg/0.5 mL PFS Kit NDC 59627-0222-05 28 days supply

D-0776-2018
Recall number
D-0776-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 44 of 67

Ibrance 125 mg cap NDC 00069-0189-21 28 days supply

D-0777-2018
Recall number
D-0777-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 45 of 67

Glatiramer Acetate 40 mg/mL NDC 00378-6961-12 28 days supply

D-0778-2018
Recall number
D-0778-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 46 of 67

Xalkori 250 mg cap NDC 00069-8140-20 30 days supply

D-0779-2018
Recall number
D-0779-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 47 of 67

Temozolomide 20 mg NDC 43975-0253-05 28 days supply

D-0780-2018
Recall number
D-0780-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 48 of 67

Temozolomide 250 mg NDC 43975-0257-05 28 days supply

D-0781-2018
Recall number
D-0781-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 49 of 67

Gleevec 100 mg tablet NDC 00078-0401-34 30 days supply

D-0782-2018
Recall number
D-0782-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 50 of 67

Sprycel 80 mg tablet NDC 00003-0855-22 30 days supply

D-0783-2018
Recall number
D-0783-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 51 of 67

Sprycel 100 mg tablet NDC 00003-0852-22 30 days supply

D-0784-2018
Recall number
D-0784-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 52 of 67

Cyclophosphamide 50 mg cap NDC 00054-0383-25 28 days supply

D-0785-2018
Recall number
D-0785-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 53 of 67

Dexamethasone 4 mg tablet NDC 49884-0087-01 28 days supply

D-0786-2018
Recall number
D-0786-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 54 of 67

Sutent 37.5 mg capsules x28 NDC 00069-0830-38 28 days supply

D-0787-2018
Recall number
D-0787-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 55 of 67

Sutent 50 mg capsules x28 NDC 00069-0550-38 42 days supply

D-0788-2018
Recall number
D-0788-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 56 of 67

Imatinib Mesylate Tablet 400 mg NDC 60505-2901-03 30 days supply

D-0789-2018
Recall number
D-0789-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 57 of 67

Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply

D-0790-2018
Recall number
D-0790-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 58 of 67

Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply

D-0791-2018
Recall number
D-0791-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 59 of 67

Bendeka 25 mg/mL 4 mL MDVPF NDC 63459-0348-04 28 days supply

D-0792-2018
Recall number
D-0792-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 60 of 67

Ondansetron 8 mg tablet NDC 57237-0076-30 28 days supply

D-0793-2018
Recall number
D-0793-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 61 of 67

Letrozole 2.5 mg tab NDC 51991-0759-33 30 days supply

D-0794-2018
Recall number
D-0794-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 62 of 67

Perjeta 420 mg/14 mL SDV Vials 50242-0145-01 21 days supply

D-0795-2018
Recall number
D-0795-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 63 of 67

Zarxio 300 mcg/0.5 mL PFS NDC 14 days supply

D-0796-2018
Recall number
D-0796-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 64 of 67

Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply

D-0797-2018
Recall number
D-0797-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 65 of 67

OPDIVO 40 mg/4 mL SDV NDC 00003-3772-11 28 days supply

D-0798-2018
Recall number
D-0798-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 66 of 67

Kisqali 600 Dose 63 tablet 200 mg NDC 00078-0874-63 28 days supply

D-0799-2018
Recall number
D-0799-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL

drug · product 67 of 67

Lupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply

D-0800-2018
Recall number
D-0800-2018
Initiated
April 03, 2018
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

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

Distribution pattern

MS, LA, AR, IL, FL