Multi-event February 2023 FDA Recall Drug by Denver Solutions, Llc Dba Leiters Health

This Multi-event Class II drug recall was voluntarily initiated by Denver Solutions, Llc Dba Leiters Health on February 21, 2023 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0444-2023 TERMINATED D-0443-2023 TERMINATED D-0442-2023 TERMINATED D-0445-2023 TERMINATED

Recall Number: D-0444-2023

Reason for Recall
CGMP DEVIATIONS
Initiated
02-21-2023
Reported
03-15-2023
Quantity
1212 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91762
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.
Denver Solutions, LLC DBA Leiters Health
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States including VA or other Government facilities
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-11-2024
Product Description About Product Description
Full technical description of the product.
Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82

Batch or Lot Expiration Information

Lot# : 2231017, Exp. Date 3/12/2023

Recall Number: D-0443-2023

Reason for Recall
CGMP DEVIATIONS
Initiated
02-21-2023
Reported
03-15-2023
Quantity
325,300 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91762
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.
Denver Solutions, LLC DBA Leiters Health
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States including VA or other Government facilities
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-11-2024
Product Description About Product Description
Full technical description of the product.
Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15

Batch or Lot Expiration Information

Lot# : 2230895, Exp. Date 3/5/2023; 2230911, Exp. Date 3/11/2023; 2230913, Exp. Date 3/18/2023; 2230994, Exp. Date 3/27/2023; 2231006, Exp. Date 4/1/2023; 2231109, Exp. Date 4/19/2023; 2231126, Exp. Date 5/6/2023; 2231134, Exp. Date 5/10/2023; 2231140, Exp. Date 5/14/2023; 2231142, Exp. Date 5/20/2023; 2231156, Exp. Date 5/29/2023; 2231273, Exp. Date 6/3/2023; 2231285, Exp. Date 6/10/2023; 2231299, Exp. Date 6/17/2023; 2231331, Exp. Date 6/26/2023; 2330014, Exp. Date 7/9/2023; 2330025, Exp. Date 7/15/2023

Recall Number: D-0442-2023

Reason for Recall
CGMP DEVIATIONS
Initiated
02-21-2023
Reported
03-15-2023
Quantity
13,445 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91762
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.
Denver Solutions, LLC DBA Leiters Health
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States including VA or other Government facilities
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-11-2024
Product Description About Product Description
Full technical description of the product.
Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11

Batch or Lot Expiration Information

Lot# : 2230960, Exp date 3/12/2023; 2231080, Exp date 4/9/2023.

Recall Number: D-0445-2023

Reason for Recall
CGMP DEVIATIONS
Initiated
02-21-2023
Reported
03-15-2023
Quantity
8,136 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91762
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.
Denver Solutions, LLC DBA Leiters Health
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States including VA or other Government facilities
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-11-2024
Product Description About Product Description
Full technical description of the product.
Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94

Batch or Lot Expiration Information

Lot# : 2231026, Exp. Date 2/23/2023; 2231051, Exp. Date 3/11/2023; 2231156, Exp. Date 5/29/2023; 2231163, Exp. Date 3/26/2023; 223130, Exp. Date 4 5/7/2023; 2231308, Exp. Date 5/11/2023