Drug Enforcement D-0070-2024

Labeling: Not Elsewhere Classified

Status

Terminated

Classification

Class III

Report Date

November 1, 2023

Termination Date

August 15, 2024

Product Information

Product description
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
Product quantity
6,276 IV bags
Reason for recall
Labeling: Not Elsewhere Classified
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
USA Nationwide

Location & Firm

Recalling firm
Denver Solutions, LLC DBA Leiters Health
Address
13796 Compark Blvd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0070-2024
Event ID
93178
Recall initiation date
October 4, 2023
Center classification date
October 26, 2023
Code info
Lot#: 2330956, Exp. 10/23/2023; 2330964, Exp. 10/24/2023; 2331014, Exp. 11/6/2023; 2331033, Exp. 11/8/2023
More code info
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