Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manu
Summary
The FDA issued a Class II for Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx by Safecor Health, LLC. Reason: Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm..
Details
Source
Drug Recall
External ID
D-0214-2026
Action Date
2025-12-10
Status
Ongoing
Category
drug
Product Description
Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26605. NDC: 67457-426-12 with Safecor Health LLC KITCHECK RFID Tag attached with incorrect serial numbers: KITCHECK 8001-03A3,00000000,003A-2560, and 8001-03A3,00000000,003A-2D3B.
Lot/Code Info: Lot 25381993 and 25391516, Exp 12/31/2026
Quantity Affected: 800 1mL vials
Reason for Recall
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Distribution
Distributed in Massachusetts
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-10
Company
Woburn, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 51 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Safecor Health, LLC has 14 FDA actions in our database, including 14 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (Safecor Health, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Safecor Health, LLC have FDA actions?
Safecor Health, LLC has 14 FDA actions in our database, including 14 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0214-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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