← FDA ENFORCEMENT
D-0432-2024Class II

IntegraDose Compounding Services LLC

Recalling firm
IntegraDose Compounding Services LLC
Product type
Drug
Status
Ongoing
Report date
2024-04-10
Distribution
Nationwide within the U.S
Firm state
MN
Product quantity
187 cassettes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility: leaking bags

Product description

fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1

Code / lot info

Lot#: 20231020FEN-1, Exp: 04/17/2024

Other recalls SPEQ maps to Environmental Monitoring
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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.