Multi-event September 2021 FDA Recall Drug by Integradose Compounding Services Llc

This Multi-event Class II drug recall was voluntarily initiated by Integradose Compounding Services Llc on September 17, 2021 for the product Drug. The FDA reported the reason for recall as lack of sterility assurance.. The product was distributed in NH, MA, MN and the recall is currently terminated.

Reported Recall Events

D-0897-2021 TERMINATED D-0896-2021 TERMINATED

Recall Number: D-0897-2021

Reason for Recall
Lack of sterility assurance.
Initiated
09-17-2021
Reported
10-06-2021
Quantity
589 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88731
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.
IntegraDose Compounding Services LLC
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.
NH, MA, MN
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-02-2022
Product Description About Product Description
Full technical description of the product.
ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC: 71139-7153-1

Batch or Lot Expiration Information

Lot# Lot, expiry: 20210722CEF-2, exp 09/20/2021; 20210728CEF-1, exp 09/26/2021

Recall Number: D-0896-2021

Reason for Recall
Lack of sterility assurance.
Initiated
09-17-2021
Reported
10-06-2021
Quantity
2,614 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88731
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.
IntegraDose Compounding Services LLC
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.
NH, MA, MN
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-02-2022
Product Description About Product Description
Full technical description of the product.
ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-7087-1

Batch or Lot Expiration Information

Lot# Lot, expiry: Lot 20210803CEF-1, exp 09/17/2021; Lot 20210805CEF-3, 09/19/2021; Lots 20210806CEF-1, 20210806CEF-2, exp 09/20/2021; Lots 20210809CEF-1, 20210809CEF-2, exp 09/23/2021; Lot 20210810CEF-1, exp 09/24/2021; Lot 20210811CEF-1, exp 09/25/2021; Lot 20210812CEF-1, exp 09/26/2021