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

This Multi-event Class III drug recall was voluntarily initiated by Denver Solutions, Llc Dba Leiters Health on October 4, 2023 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0072-2024 TERMINATED D-0071-2024 TERMINATED D-0070-2024 TERMINATED

Recall Number: D-0072-2024

Reason for Recall
Labeling: Not Elsewhere Classified
Initiated
10-04-2023
Reported
11-01-2023
Quantity
25,908 IV bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93178
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2024
Product Description About Product Description
Full technical description of the product.
VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-029-68.

Batch or Lot Expiration Information

Lot# : 2330792, Exp. 12/17/23; 2330801, Exp. 12/26/23; 2330821, 10/15/23; 2330823, Exp. 10/21/23; 2330825, Exp. 10/27/23; 2330846, Exp. 10/28/23; 2330847, Exp. 11/03/23; 2330856, 11/17/23; 2330858, Exp. 12/03/23; 2330860, 12/15/23; 2330866, Exp. 12/29/23; 2331053, Exp. 01/13/24.

Recall Number: D-0071-2024

Reason for Recall
Labeling: Not Elsewhere Classified
Initiated
10-04-2023
Reported
11-01-2023
Quantity
33,480 IV Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93178
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2024
Product Description About Product Description
Full technical description of the product.
VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-028-68.

Batch or Lot Expiration Information

Lot# : 2330781, Exp. 10/19/23; 2330791, Exp. 10/29/23; 2330795, Exp. 11/02/23; 2330800, Exp. 11/09/23; 2330807, Exp. 11/11/23; 2330812, Exp. 11/16/23; 2330816, Exp. 11/19/23; 2330822, 10/20/23; 2330897,11/23/23; 2330899, 11/25/23; 2330901, 11/26/23; 2330918, 11/30/23; 2330943, 01/12/24; 2331050, 01/14/24; 2331064, 01/21/24; 2331102, Exp. 01/25/24.

Recall Number: D-0070-2024

Reason for Recall
Labeling: Not Elsewhere Classified
Initiated
10-04-2023
Reported
11-01-2023
Quantity
6,276 IV bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93178
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2024
Product Description About Product Description
Full technical description of the product.
Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-157-70

Batch or Lot Expiration Information

Lot# : 2330956, Exp. 10/23/2023; 2330964, Exp. 10/24/2023; 2331014, Exp. 11/6/2023; 2331033, Exp. 11/8/2023