Multi-event February 2020 FDA Recall Drug by Redline Pharmacy Solutions

This Multi-event Class II drug recall was voluntarily initiated by Redline Pharmacy Solutions on February 24, 2020 for the product Drug. The FDA reported the reason for recall as lack of processing controls. The product was distributed in Sold to patients in Nebraska and the recall is currently terminated.

Reported Recall Events

D-1010-2020 TERMINATED D-1009-2020 TERMINATED D-1007-2020 TERMINATED D-1006-2020 TERMINATED D-1011-2020 TERMINATED D-1008-2020 TERMINATED

Recall Number: D-1010-2020

Reason for Recall
Lack Of Processing Controls
Initiated
02-24-2020
Reported
03-18-2020
Quantity
3 doses

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85081
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Redline Pharmacy Solutions
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Sold to patients in Nebraska
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-31-2022
Product Description About Product Description
Full technical description of the product.
Vancomycin 900MG in 100ML 0.9% NACL Injectable, Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901

Batch or Lot Expiration Information

Lot# Lot 02242020@8

Recall Number: D-1009-2020

Reason for Recall
Lack Of Processing Controls
Initiated
02-24-2020
Reported
03-18-2020
Quantity
8 doses

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85081
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Redline Pharmacy Solutions
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Sold to patients in Nebraska
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-31-2022
Product Description About Product Description
Full technical description of the product.
Ertapenem in 100ML 0.9% NACL 1GM Injectable, Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901

Batch or Lot Expiration Information

Lot# Lot 02242020@7

Recall Number: D-1007-2020

Reason for Recall
Lack Of Processing Controls
Initiated
02-24-2020
Reported
03-18-2020
Quantity
1 20 ml syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85081
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Redline Pharmacy Solutions
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Sold to patients in Nebraska
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-31-2022
Product Description About Product Description
Full technical description of the product.
Morphine Sulfate, 20 mg/mL intrathecal, 20 mL per syringe. Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901

Batch or Lot Expiration Information

Lot# Lot 02242020@2

Recall Number: D-1006-2020

Reason for Recall
Lack Of Processing Controls
Initiated
02-24-2020
Reported
03-18-2020
Quantity
2x5 ml bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85081
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Redline Pharmacy Solutions
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Sold to patients in Nebraska
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-31-2022
Product Description About Product Description
Full technical description of the product.
Acetylcysteine Ophthalmic 10% Solution, 5 mL per dropper bottle (10ML). Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901

Batch or Lot Expiration Information

Lot# Lot 02242020@1

Recall Number: D-1011-2020

Reason for Recall
Lack Of Processing Controls
Initiated
02-24-2020
Reported
03-18-2020
Quantity
1 40 ml syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85081
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Redline Pharmacy Solutions
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Sold to patients in Nebraska
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-31-2022
Product Description About Product Description
Full technical description of the product.
Morphine Sulfate (MITIGO), 5 mg/mL intrathecal, 40 mL per syringe. Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901

Batch or Lot Expiration Information

Lot# Lot 02242020@14

Recall Number: D-1008-2020

Reason for Recall
Lack Of Processing Controls
Initiated
02-24-2020
Reported
03-18-2020
Quantity
16 doses

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85081
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Redline Pharmacy Solutions
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Sold to patients in Nebraska
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-31-2022
Product Description About Product Description
Full technical description of the product.
Daptomycin, 500MG in 0.9% NACL 100ML Injectable Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901

Batch or Lot Expiration Information

Lot# Lots 02242020@3, 02242020@9