Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, Compounde
Summary
The FDA issued a Class II for Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Stacle by Pine Pharmaceuticals, LLC. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0065-2024
Action Date
2023-10-25
Status
Terminated
Category
drug
Product Description
Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Lot/Code Info: Lot #: 68680, Exp. Date 12/4/2023
Quantity Affected: 136 syringes
Reason for Recall
Lack of Assurance of Sterility
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-02
Company
Tonawanda, NY
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 48 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Pine Pharmaceuticals, LLC has 19 FDA actions in our database, including 19 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 (Pine Pharmaceuticals, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Pine Pharmaceuticals, LLC have FDA actions?
Pine Pharmaceuticals, LLC has 19 FDA actions in our database, including 19 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0065-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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