Drug recalls

Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific…

Carolina Infusion, LLC · Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

Class IIOngoingD-0024-2027
Status
Ongoing
City
Ridgeland
State
SC
Country
United States
Classification
Class II
Product type
Drugs
Event ID
99867
Recalling firm
Carolina Infusion, LLC
Address 1
95 Bees Creek Rd
Address 2
N/A
Postal code
29936-7540
Voluntary mandated
Voluntary: Firm initiated
Initial firm notification
E-Mail
Distribution pattern
Nationwide within the U.S
Recall number
D-0024-2027
Product quantity
3 ML in patient specific syringe dose
Reason for recall
Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
Recall initiation date
20260910
Center classification date
20261008
Report date
20261014
Code info
Lot:08042026@8, BUD: 9/18/2026.
Product description

Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.