Multi-event December 2022 FDA Recall Drug by Pharmacy Innovations

This Multi-event Class II drug recall was voluntarily initiated by Pharmacy Innovations on December 22, 2022 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0216-2023 TERMINATED D-0233-2023 TERMINATED D-0202-2023 TERMINATED D-0205-2023 TERMINATED D-0223-2023 TERMINATED D-0221-2023 TERMINATED D-0213-2023 TERMINATED D-0196-2023 TERMINATED D-0204-2023 TERMINATED D-0211-2023 TERMINATED D-0215-2023 TERMINATED D-0231-2023 TERMINATED D-0195-2023 TERMINATED D-0193-2023 TERMINATED D-0198-2023 TERMINATED D-0236-2023 TERMINATED D-0185-2023 TERMINATED D-0224-2023 TERMINATED D-0210-2023 TERMINATED D-0220-2023 TERMINATED D-0228-2023 TERMINATED D-0243-2023 TERMINATED D-0197-2023 TERMINATED D-0189-2023 TERMINATED D-0219-2023 TERMINATED D-0240-2023 TERMINATED D-0191-2023 TERMINATED D-0209-2023 TERMINATED D-0227-2023 TERMINATED D-0238-2023 TERMINATED D-0199-2023 TERMINATED D-0234-2023 TERMINATED D-0186-2023 TERMINATED D-0207-2023 TERMINATED D-0201-2023 TERMINATED D-0230-2023 TERMINATED D-0194-2023 TERMINATED D-0241-2023 TERMINATED D-0226-2023 TERMINATED D-0206-2023 TERMINATED D-0203-2023 TERMINATED D-0187-2023 TERMINATED D-0214-2023 TERMINATED D-0218-2023 TERMINATED D-0237-2023 TERMINATED D-0229-2023 TERMINATED D-0232-2023 TERMINATED D-0225-2023 TERMINATED D-0222-2023 TERMINATED D-0192-2023 TERMINATED D-0242-2023 TERMINATED D-0190-2023 TERMINATED D-0212-2023 TERMINATED D-0239-2023 TERMINATED D-0235-2023 TERMINATED D-0200-2023 TERMINATED D-0217-2023 TERMINATED D-0188-2023 TERMINATED D-0208-2023 TERMINATED

Recall Number: D-0216-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
KETAMINE 50MG/ML (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221031@55

Recall Number: D-0233-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
PROGESTERONE-GS OIL- 100MG/ML (2ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221116@36

Recall Number: D-0202-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
Dexpanthenol/Pyridoxine/Hydroxocobalamin-PF- 250MG/100MG/1MG/ML (1ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221012@64; t20221114@18

Recall Number: D-0205-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
Estradiol 0.05% OPH Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221021@9

Recall Number: D-0223-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
MITOMYCIN 0.2MG/ML (1ML DROPTAINER) OPH SOLUTION; MITOMYCIN 0.2MG/ML (1ML VIAL) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221004@8 t20221011@36

Recall Number: D-0221-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
METHOTREXATE INTRAVITREAL (1ML VIAL) 4MG/ML (400MCG/0.1ML) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221011@36

Recall Number: D-0213-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
GLYCERIN/LIDOCAINE HCL/EPINEPHRINE 31%(V/V)/0.17%/0.00017% (10ML VIALS); GLYCERIN/LIDOCAINE HCL/EPINEPHRINE 48.7%(W/V)/0.67%/0.00067% (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221116@36 t20221117@11

Recall Number: D-0196-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
Buprenorphine HCL 0.9 MG/ML (25ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221118@33

Recall Number: D-0204-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
EDETATE DISODIUM (VET) 1% (3ML droptainer) OPH Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221116@36 t20221005@3 t20221021@32 t20221110@60 t20221130@10

Recall Number: D-0211-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
GLYCERIN 72% (W/V) (15ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221117@11

Recall Number: D-0215-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
HYDROXOCOBALAMIN-PF- 1MG/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221116@36 t20221117@11 t20221111@61

Recall Number: D-0231-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
POLIDOCANOL 50MG/ML (5%) (30ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221025@32

Recall Number: D-0195-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
BSS Plus/Lidocaine Opth 1% (1ML syringe) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221004@47

Recall Number: D-0193-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
Apomorphine HCL 2MG/ML (10ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221108@46

Recall Number: D-0198-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
Cholecalciferol (Vitamin D3) 100,000U/ML Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221130@14

Recall Number: D-0236-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
SEMAGLUTIDE 0.5MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 1MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 2MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 4MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 5.4MG/ML (0.5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221026@52 t20221102@11 t20221004@44 t20221116@36 t20221011@36

Recall Number: D-0185-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
Dutasteride 0.1% (1.5ML VIAL) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# 20221012@21 t20221025@32 t20221109@7

Recall Number: D-0224-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
MITOMYCIN 0.4MG/ML (1ML DROPTAINER) OPH SOLUTION; MITOMYCIN 0.4MG/ML (1ML VIAL) OPH SOLUTION; MITOMYCIN 0.4MG/ML (4ML VIAL) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221108@20 t20221026@25 t20221116@36

Recall Number: D-0210-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
GLUTATHIONE L REDUCED 100MG/ML (2ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 200MG/ML (1ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 220MG/ML (30ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED 500MG/ML (1ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED 500MG/ML (2ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED-PF- 200MG/ML (2ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221129@68 t20221025@32 t20221025@33 t20221114@27 t20221021@40 t20221116@36

Recall Number: D-0220-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
METHION/INOSIT/CHOLINE/CYANOCOBAL 25MG/50MG/50MG/1MG/ML (1ML VIAL) INJECTABLE; METHION/INOSIT/CHOLINE/METHYLCOBAL 15MG/50MG/100MG/1MG/ML (1ML VIAL) INJECTABLE; METHION/INOSIT/CHOLINE/RIBOFLA/NIACINAMIDE/PYRIDOX/ASCORBIC ACID 15.625MG/31.25MG/31.25MG/6.25MG/62.5MG/6.25MG/62.5MG/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221011@25 t20221025@48 t20221115@36

Recall Number: D-0228-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
PE1/PAPAV/PHEN 20MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN 30MCG/30MCG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN 5.88MCG/17.65MG/0.588MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT (1ML) 10MCG/30MG/2MG/ML INJECTABLE PE1/PAPAV/PHENT 10MCG/18MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 10MCG/30MG/0.5MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 10MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 10MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 11.8MCG/18MG/0.6MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 12.2MCG/19.29MG/1.22MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 12.5MCG/24MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 20MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 20MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 20MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 30MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 30MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 30MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 40MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5.88MCG/17.65MG/0.588MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5.88MCG/18MG/0.6MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5.8MCG/17.44MG/0.64MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5.9MCG/17.64MG/0.59MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 50MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 50MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5MCG/15MG/0.5MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 60MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 60MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 70MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 8.3MCG/25MG/0.83MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 80MCG/30MG/3MG (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 10MCG/12MG/1MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 10MCG/30MG/2MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 20MCG/30MG/2MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 20MCG/30MG/4MG/0.4MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 30MCG/30MG/1MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 30MCG/30MG/2MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 40MCG/30MG/4MG/0.4MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 50MCG/30MG/2MG/0.1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 60MCG/30MG/4MG/0.15MG/ML (1ML VIAL) INJECTABLE; Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221018@32 t20221108@89 t20221013@18 t20221031@11 t20221010@18 t20221101@1 20221108@18 t20221101@3 t20221027@32 t20221123@10 t20221013@15 t20221003@37 t20221021@32 t20221108@3 t20221011@36 t20221108@24 t20221021@43 t20221026@5 t20221123@15 t20221111@58 t20221013@15 t20221116@36 t20221128@2 t20221011@36 t20221108@24 t20221116@57 t20221007@33 t20221111@39 t20221011@36 t20221108@24 t20221128@45 t20221116@36 t20221011@36 t20221116@36 t20221104@34 t20221018@61 t20221116@36 t20221111@19 t20221011@36 t20221108@24 t20221108@64 t20221116@36 t20221117@11 t20221114@21 t20221108@33 t20221010@22 t20221004@44 t20221121@49

Recall Number: D-0243-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
VORICONAZOLE 10MG/ML (10ML DROPPER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221025@32

Recall Number: D-0197-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
Ceftazidime Intravitreal (1ML vial) 22.5 MG/ML(2.25MG/0.1ML) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221028@11

Recall Number: D-0189-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
Minoxidil 0.75% (1.5ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221011@36

Recall Number: D-0219-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
MAGNESIUM CHLORIDE HEXAHYDRATE-PF- 200MG/ML (5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221011@36

Recall Number: D-0240-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
TOBRAMYCIN FORTIFIED 15MG/ML OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221104@17

Recall Number: D-0191-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
Acetylcysteine 10% Ophthalmic Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221011@36 t20221108@24

Recall Number: D-0209-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
GENTAMICIN BLADDER 0.08MG/ML (60ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.48MG/ML (30ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.48MG/ML (60ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.64MG/ML (25ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.64MG/ML (25ML SYRINGE) IRRIGATION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221117@11 t20221116@36 t20221011@36 t20221108@24 t20221125@30 t20221020@64

Recall Number: D-0227-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
PE1/PAPAV/ATROP/CHLOPROM** 7MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 100MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 15MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 30MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM** 7MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE; Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221025@7 t20221116@36 20221114@41 t20221117@5 t20221116@36

Recall Number: D-0238-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
TESTOSTERONE 3% (4GM TUBE) OPHTH OINTME TESTOSTERONE CYP/ANASTROZOLE-GS OIL- 200MG/0.5MG/ML (3.5ML VIAL) INJECTABLE TESTOSTERONE CYP/ANASTROZOLE-GS OIL- 200MG/1MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP/ANASTROZOLE-GS OIL- 200MG/1MG/ML (3ML VIAL) INJECTABLE TESTOSTERONE CYP/ANASTROZOLE-GS OIL- 200MG/1MG/ML (4ML VIAL) INJECTABLE TESTOSTERONE CYP/ESTRADIOL CYP-SS OIL- 50MG/2MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP/ESTRADIOL CYP-SS OIL- 50MG/2MG/ML (1ML VIAL) INJECTABLE TESTOSTERONE CYP/ESTRADIOL CYP-SS OIL- 50MG/2MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP/PROP(80/20)-GS OIL- 200MG/ML (5ML VIAL) INJECTABLE TESTOSTERONE CYP-CS OIL-PF- 80MG/ML (0.7ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 100MG/ML (1.2ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 150MG/ML (3.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 150MG/ML (4ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 200MG/ML (2.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 200MG/ML (3.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 200MG/ML (3ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 200MG/ML (4ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 20MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 20MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 25MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 25MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 25MG/ML (3.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 300MG/ML (5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 50MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 50MG/ML (1ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 50MG/ML (2.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 50MG/ML (3.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 75MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 75MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 80MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 80MG/ML (1ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL-PF- 75MG/ML (1ML VIAL) INJECTABLE TESTOSTERONE CYP-OLIVE OIL- 50MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP-SS OIL- 125MG/ML (5ML VIAL) INJECTABLE TESTOSTERONE CYP-SS OIL- 200MG/ML (5ML VIAL) INJECTABLE TESTOSTERONE CYP-SS OIL- 50MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP-SS OIL-PF- 80MG/ML (1ML VIAL) INJECTABLE TESTOSTERONE ENAN-GS OIL-PF- 300MG/ML (0.4ML VIAL) INJECTABLE TESTOSTERONE-PF- 50MG/ML (5%) (1ML DROPTAINERS) OPHTHALMIC, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221011@42 t20221011@36 t20221116@36 t20221117@11 t20221116@36 t20221117@11 t20221011@36 t20221108@24 t20221007@33 t20221116@36 t20221129@68 t20221011@36 t20221108@24 t20221116@36 t20221014@45 t20221116@54 t20221116@55 t20221011@36 t20221024@36 t20221004@38 t20221109@46 t20221027@6 t20221010@8 t20221109@42 t20221115@21 t20221010@50 t20221115@19 t20221116@36 t20221117@11 t20221010@25 t20221116@36 t20221017@7 t20221117@23 t20221116@36 t20221117@11 t20221103@11 t20221003@7 t20221024@58 t20221018@10 t20221011@1 t20221121@43 t20221027@38

Recall Number: D-0199-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
Clindamycin/EDTA Calcium 4.1667MG/0.333MG/ML (30ML syringe) Irrigation, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221109@41

Recall Number: D-0234-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
PROSTAGLANDIN (PE1) 45MCG (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 17MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 20MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 22.5MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 23MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 30MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 40MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 44.5MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 45MCG/ML (3ML VIAL) INJECTABLE PROSTAGLANDIN E1 50MCG/ML (1ML VIAL) INJECTION PROSTAGLANDIN E1 60MCG/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221027@29 t20221020@25 t20221109@17 t20221118@8 t20221129@68 t20221027@11 t20221010@24 t20221010@61 t20221005@2 t20221024@22 t20221116@36 t20221004@12

Recall Number: D-0186-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
Chlorpheniramine/Hyoscyamine (1ML) 10MG/0.25MG/ML Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221026@41

Recall Number: D-0207-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
Ethyl Alcohol 95% (5ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221013@15

Recall Number: D-0201-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
DEXAMETHASONE 16MG/ML (3ML VIAL) INJECTABLE; DEXAMETHASONE 24MG/ML INJECTABLE; DEXAMETHASONE-PF- 0.1% (1ML DROPPER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221116@36 t20221117@11 t20221108@87

Recall Number: D-0230-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID (10ML VIAL) 50MG/50MG/ML (5%/5%) INJECTABLE; Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221025@32

Recall Number: D-0194-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
Atropine sulfate 0.05%, 1ML dropper, and Atropine sulfate 0.01%, 1 ML dropper, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221025@32 t20221025@33

Recall Number: D-0241-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
VANCOMYCIN FORTIFIED 10MG/ML (1ML DROPTAINER) OPH SOLUTION VANCOMYCIN FORTIFIED 14MG/ML (3ML DROPTAINER) OPH SOLUTION VANCOMYCIN FORTIFIED-STS- 50MG/ML OPH SOLUTION VANCOMYCIN-STS- 25MG/ML (2ML DROPTAINER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221122@15 t20221110@28 t20221027@33 t20221020@5

Recall Number: D-0226-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
PAPAVERINE/PHENTOLAMINE 30MG/0.5MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/1MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/2MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/3MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/5MG/ML (1ML VIAL) INJECTABLE; Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221011@7 t20221020@34 t20221018@58 t20221013@15 t20221104@39

Recall Number: D-0206-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
ESTRADIOL CYP/TEST CYP- SS OIL- 2MG/50MG/ML (1.5ML VIAL) INJECTABLE; ESTRADIOL CYP/TEST CYP -SS OIL- 2MG/25MG/ML (1ML VIAL) INJECTABLE; ESTRADIOL CYP-CS OIL- 5MG/ML (1.25ML VIAL) INJECTABLE; ESTRADIOL CYP-GS OIL- 5MG/ML (1ML VIAL) INJECTABLE ESTRADIOL CYP-SS OIL- 5MG/ML (1.5ML VIAL) INJECTABLE; ESTRADIOL CYP-SS OIL- 5MG/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221109@7 t20221027@6 t20221010@8 t20221116@36 t20221111@45 t20221026@41

Recall Number: D-0203-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
Edetate Calcium Disodium 400MG/ML (30ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221013@15

Recall Number: D-0187-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
Hydroxocobalamin 25MG/ML (2ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221025@33

Recall Number: D-0214-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
HEPARIN/LIDO HCL/SODIUM BICARB 100U/2MG/16.8MG/ML (20ML SYRINGE) IRRIGATION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221011@36; t20221108@24

Recall Number: D-0218-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
LIDOCAINE-PF- 5% (5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221011@36 t20221108@24

Recall Number: D-0237-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
TACROLIMUS 0.03% OPH SOLUTION TACROLIMUS 0.1% (1ML DROPTAINER) OPH SOLUTION TACROLIMUS -CORN OIL- 0.03% OPH SOLUTION TACROLIMUS-VET- 0.02% (10ML DROPPER) OPHTHALMIC TACROLIMUS-VET- 0.02% (15ML DROPPER) OPHTHALMIC TACROLIMUS-VET- 0.02% (5ML DROPPER) OPHTHALMIC TACROLIMUS-VET- 0.03% (10ML DROPPER) OPHTHALMIC, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221011@25 t20221011@55 t20221020@26 t20221104@44 t20221027@6 20221019@44 t20221026@41

Recall Number: D-0229-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
PHENOL 10% (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# 20221017@50

Recall Number: D-0232-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
POLYHEXAMETHYLENE BIGUANIDE 0.2MG/ML (0.2%) (10ML DROPTAINER) OPTH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221025@32

Recall Number: D-0225-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
NADH 10MG/ML (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221108@46

Recall Number: D-0222-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
METHYLCOBALAMIN 12.5MG/ML (1ML VIAL) INJECTABLE METHYLCOBALAMIN 25MG/ML (1.2ML VIAL) INJECTABLE; METHYLCOBALAMIN 3MG/ML (1ML VIAL) INJECTABLE; METHYLCOBALAMIN 5MG/ML (0.2ML VIAL) INJECTABLE; METHYLCOBALAMIN 5MG/ML (1ML VIAL) INJECTABLE; METHYLCOBALAMIN-PF- 12.5MG/ML (1ML VIAL) INJECTABLE; METHYLCOBALAMIN-PF- 25MG/ML (0.5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221011@25 t20221011@37 t20221018@35 t20221121@29 t20221116@36 t20221116@36 t20221116@36 t20221116@36

Recall Number: D-0192-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
Albuterol (PF/SULFURIC ACID/DYE FREE) - 3ML tube - 0.083% Inhalation Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221011@36 t20221108@24

Recall Number: D-0242-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
VITAMIN D3-AQUEOUS- 10,000IU/ML (1ML VIAL) INJECTABLE; VITAMIN D3-PF-ETHYL OLEATE- 50,000IU/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221017@25 t20221013@15

Recall Number: D-0190-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
5-Fluorouracil 1%, 2.5ML droptainer, and 5ML droptainer Ophthalmic, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221019@52 t20221013@13

Recall Number: D-0212-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
GLYCERIN STERILE 99% 2ML VIAL and 5ML VIAL, Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221004@24 t20221115@20 t20221116@36

Recall Number: D-0239-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
THIAMINE/RIBOFLA/NIACINAMI/DEXPANTH/PYRIDOX/HYDROXYCOBAL 25MG/25MG/25MG/25MG/25MG/20MG/ML (3ML VIAL) INJECTABLE THIAMINE/RIBOFLA/NIACINAMI/DEXPANTH/PYRIDOX/METHYLFOLATE/METHYLCOBAL 10MG/2.5MG/25MG/5MG/5MG/10MG/10MG/ML (1ML VIAL) INJECTABLE THIAMINE/RIBOFLAVIN/NIACINAMIDE/DEXPANTHENOL/PYRIDOXINE 50MG/1MG/100MG/3MG/2MG/ML (30ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221116@36 t20221121@42 t20221021@32

Recall Number: D-0235-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
SCOPOLAMINE HYDROBROMIDE 0.25% OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221111@37

Recall Number: D-0200-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
Cyclosporine (A) 0.1%; Cyclosporine (A) 0.2%; Cyclosporine (A) 1%; Cyclosporine (A) 2%; Cyclosporine (A) - Corn oil - 1% Oph solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221109@43 t20221108@27 t20221011@41 t20221024@3 t20221104@37 t20221025@32 t20221025@33 t20221013@15 t20221017@5

Recall Number: D-0217-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
LEVEMIR-STS- 100U/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221116@36

Recall Number: D-0188-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
Methylcobalamin 1MG/ML (1ML vial); Methylcobalamin 3MG/ML (1ML vial); Methylcobalamin 5MG/ML (1ML vial) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221021@36 t20221025@32 t20221025@33

Recall Number: D-0208-2023

Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Initiated
12-22-2022
Reported
02-01-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91332
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.
Pharmacy Innovations
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
FLURBIPROFEN -CORN OIL- 0.04% (3ML DROPTAINER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Batch or Lot Expiration Information

Lot# t20221116@36