Multi-event April 2018 FDA Recall Drug by Kroger Specialty Pharmacy, Inc.
This Multi-event Class II drug recall was voluntarily initiated by Kroger Specialty Pharmacy, Inc. on April 3, 2018 for the product Drug. The FDA reported the reason for recall as lack of processing controls.. The product was distributed in MS, LA, AR, IL, FL and the recall is currently terminated.
Reported Recall Events
D-0797-2018 D-0763-2018 D-0778-2018 D-0759-2018 D-0748-2018 D-0779-2018 D-0795-2018 D-0757-2018 D-0762-2018 D-0777-2018 D-0772-2018 D-0776-2018 D-0742-2018 D-0734-2018 D-0743-2018 D-0754-2018 D-0753-2018 D-0782-2018 D-0750-2018 D-0747-2018 D-0775-2018 D-0746-2018 D-0788-2018 D-0784-2018 D-0749-2018 D-0738-2018 D-0751-2018 D-0767-2018 D-0737-2018 D-0761-2018 D-0741-2018 D-0769-2018 D-0773-2018 D-0789-2018 D-0735-2018 D-0768-2018 D-0771-2018 D-0799-2018 D-0794-2018 D-0792-2018 D-0791-2018 D-0752-2018 D-0756-2018 D-0765-2018 D-0785-2018 D-0744-2018 D-0770-2018 D-0755-2018 D-0780-2018 D-0766-2018 D-0796-2018 D-0740-2018 D-0736-2018 D-0758-2018 D-0786-2018 D-0745-2018 D-0783-2018 D-0739-2018 D-0787-2018 D-0798-2018 D-0781-2018 D-0800-2018 D-0774-2018 D-0790-2018 D-0793-2018 D-0760-2018 D-0764-2018
Recall Number: D-0797-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0763-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Cimzia 200 mg/mL PFS Kit #2 NDC 50474-0710-79 28 days supply.
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0778-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Glatiramer Acetate 40 mg/mL NDC 00378-6961-12 28 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0759-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Vosevi 400/100/100 mg Tablets #28 NDC 61958-2401-01 28 days supply.
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0748-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Prolia 60 mg/1 mL PF syringe NDC 55513-0710-01 180 days supply.
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0779-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Xalkori 250 mg cap NDC 00069-8140-20 30 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0795-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Perjeta 420 mg/14 mL SDV Vials 50242-0145-01 21 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0757-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sodium Chloride 3% Inh. 4 mL NEP #30 NDC 00487-9003-60 30 days supply.
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0762-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Stelara 90 mg/MI PFS NDC 57894-0061-03 84 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0777-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Ibrance 125 mg cap NDC 00069-0189-21 28 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0772-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Revlimid 15 mg oral cap NDC 59572-0415-21 28 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0776-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Avonex 30 mcg/0.5 mL PFS Kit NDC 59627-0222-05 28 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0742-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Cosentyx 150 mg/mL PFS 300 mg Dose NDC 00078-0639-98, 28 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0734-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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,
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0743-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Altera Handset NDC 83490-0678-05 56 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0754-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Azithromycin 250 mg tablet #18 TEV NDC 50111-0787-66 28 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0753-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Pulmozyme 1 mg/mL Inh. Soln. #30 NDC 50242-0100-40 30 days supply.
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0782-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Gleevec 100 mg tablet NDC 00078-0401-34 30 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0750-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Orkambi 200 mg/125 mg Tablets #112 NDC 51167-0809-01 28 days supply.
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0747-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Botox 100 Units Vial NDC 00023-1145-01 90 days supply.
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0775-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Revlimid 25 mg oral cap NDC 59572-0425-21 28 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0746-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Enbrel PFS 50 mg/mL Inj #4 NDC 58406-0435-04 28 days supply;
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0788-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sutent 50 mg capsules x28 NDC 00069-0550-38 42 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0784-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sprycel 100 mg tablet NDC 00003-0852-22 30 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0749-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Kitabis Pak 300 mg/5 mL Soln PARI #56 NDC 24492-0850-56 56 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0738-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Polyethylene Glycol 3350, powder, for solution 527g BRE, Rx Only, 28 days supply, NDC 51991-0457-57
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0751-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Orkambi 100 mg/125 mg Tablets #112 NDC 51167-0700-02 28 days supply.
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0767-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Tecfidera 240 mg capsule NDC 64406-0006-02 30 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0737-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Pediasure Liq. Vanilla G+G (CAN) #24 24 days supply, NDC 70074-0558-98
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0761-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Boost VHC Oral Liquid VAN #27 NDC 43900-0182-15 27 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0741-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Taltz 80 mg/mL Pen 1-pk NDC 00002-1445-11 28 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0769-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Xtandi 40 mg capsule NDC 00469-0125-99 30 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0773-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Revlimid 20 mg oral cap NDC 59572-0420-21 28 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0789-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Imatinib Mesylate Tablet 400 mg NDC 60505-2901-03 30 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0735-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Albuterol 0.083% Inh Sol. 30 days supply, Rx Only, 39183, NDC 76204-0200-60, 30
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0768-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Pomalyst 3 mg capsule NDC 59572-0503-21 28 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0771-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Revlimid 10 mg oral cap NDC 59572-0410-28 28 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0799-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Kisqali 600 Dose 63 tablet 200 mg NDC 00078-0874-63 28 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0794-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Letrozole 2.5 mg tab NDC 51991-0759-33 30 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0792-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Bendeka 25 mg/mL 4 mL MDVPF NDC 63459-0348-04 28 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0791-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0752-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Bethkis 300 mg/4 mL Ampule #56 NDC 10122-0820-56 56 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0756-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
N/A
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
MVW Complete Softgels NDC 58204-0004-00 30 days supply; MVW Complete Chew Vitamin Grape NDC 58204-0004-15 30 days supply.
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0765-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Copaxone 40 mg Injection (12) NDC 68546-0325-12 28 days supply.
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0785-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Cyclophosphamide 50 mg cap NDC 00054-0383-25 28 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0744-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Cayston 75 mg Inh. Soln. SDV NDC 61958-0901-01 56 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0770-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Promacta 50 mg tablet NDC 00078-0686-15 30 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0755-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Creon DR 24,000 Units Capsule #250 NDC 00032-1224-07 30 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0780-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Temozolomide 20 mg NDC 43975-0253-05 28 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0766-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Copaxone 20 mg Injection PFS (30) NDC 68546-0317-30 30 days supply.
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0796-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Zarxio 300 mcg/0.5 mL PFS NDC 14 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0740-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Otezla 30 mg tablet NDC 59572-0631-06 30 days supply;
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0736-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Kalydeco 150 mg tablet blister, 28 days supply, Rx Only, 39183, NDC 51167-0200-01
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0758-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Xolair 150 mg SDV NDC 50242-0040-62 28 days
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0786-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Dexamethasone 4 mg tablet NDC 49884-0087-01 28 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0745-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Repatha 140 mg/mL Sureclick AI 2-pk NDC 55513-0760-02 28 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0783-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sprycel 80 mg tablet NDC 00003-0855-22 30 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0739-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Pulmicort Respules 0.5 mg/2mL s, 30 days supply, NDC 00186-1989-04
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0787-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sutent 37.5 mg capsules x28 NDC 00069-0830-38 28 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0798-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
OPDIVO 40 mg/4 mL SDV NDC 00003-3772-11 28 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0781-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Temozolomide 250 mg NDC 43975-0257-05 28 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0800-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0774-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Revlimid 5 mg oral cap NDC 59572-0405-28 28 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0790-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0793-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Ondansetron 8 mg tablet NDC 57237-0076-30 28 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0760-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Dupixent 300 mg/2 mL PFS #2 w/ NS NDC 00024-5914-01 28 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall Number: D-0764-2018
Lack of Processing Controls.
04-03-2018
05-16-2018
Unknown
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kroger Specialty Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, LA, AR, IL, FL
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Praluent 75 mg Pen (2 pens/Pkg) NDC 00024-5901-02 28 days supply
Batch or Lot Expiration Information
Lot# All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
