Drug Enforcement D-0296-2025

Lack of Assurance of Sterility

Status

Ongoing

Classification

Class II

Report Date

April 2, 2025

Termination Date

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Product Information

Product description
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75
Product quantity
2,310 cassettes
Reason for recall
Lack of Assurance of Sterility
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
U.S. Nationwide

Location & Firm

Recalling firm
QuVa Pharma, Inc.
Address
1075 W Park One Dr Ste 100, N/A

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

Codes & Dates

Recall number
D-0296-2025
Event ID
96446
Recall initiation date
March 6, 2025
Center classification date
March 25, 2025
Code info
Lot, expiry: Lots 10140284, 10140285, 10140315, 10140316, exp 04/08/2025; Lot 10140510, exp 04/14/2025; Lot 10140916, exp 04/24/2025
More code info
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