Drug Enforcement D-0646-2023

Lack of Assurance of Sterility

Status

Ongoing

Classification

Class II

Report Date

May 24, 2023

Termination Date

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Product Information

Product description
FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-950-25
Product quantity
308 bags
Reason for recall
Lack of Assurance of Sterility
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Missouri only

Location & Firm

Recalling firm
Apollo Care, LLC
Address
3801 Mojave Ct Ste 101, N/A

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

Codes & Dates

Recall number
D-0646-2023
Event ID
92348
Recall initiation date
May 2, 2023
Center classification date
May 18, 2023
Code info
Lot #: AC-016644, Exp. Date 05/08/2023; AC-016659, Exp. Date 09/26/2023
More code info
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