Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single U
Summary
The FDA issued a Class II for Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Off by Turbare Manufacturing. Reason: Lack of Assurance of Sterility: due to a quality control process deviation.
Details
Source
Drug Recall
External ID
D-0248-2025
Action Date
2025-03-05
Status
Completed
Category
drug
Product Description
Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single Use, This drug product was repackaged by Turbare Manufacturing, 925 Jeanette Drive, Conway, AR 72032, NDC: 83556-0101-01.
Lot/Code Info: Lot #s: 12122024@2 (BUD: 3/12/2025); 12192024@2 (BUD: 4/18/2025).
Quantity Affected: 1,147 syringes
Reason for Recall
Lack of Assurance of Sterility: due to a quality control process deviation
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-18
Company
Conway, AR
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 55 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
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 (Turbare Manufacturing) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Turbare Manufacturing have FDA actions?
This is the only FDA action we have on record for Turbare Manufacturing in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0248-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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