FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42n
Summary
The FDA issued a Class III for FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 m by STAQ Pharma, Inc.. Reason: Labeling: Incorrect or Missing Lot and/or Exp Date.
Details
Source
Drug Recall
External ID
D-0025-2026
Action Date
2025-10-22
Status
Ongoing
Category
drug
Product Description
FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0102-05.
Lot/Code Info: Lot: 25102464B, Expiry: 26NOV2025; 25102370A, Expiry: 20OCT2025; 25102369A, Expiry: 19OCT2025.
Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date
Distribution
Nationwide in the U.S.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-09
Company
Denver, CO
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 107 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
STAQ Pharma, Inc. has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (STAQ Pharma, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does STAQ Pharma, Inc. have FDA actions?
STAQ Pharma, Inc. has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0025-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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