Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX only, Safecor Health
Summary
The FDA issued a Class II for Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Droppe by Safecor Health, LLC. Reason: CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements..
Details
Source
Drug Recall
External ID
D-0082-2024
Action Date
2023-11-08
Status
Terminated
Category
drug
Product Description
Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX only, Safecor Health, LLC, Woburn, MA 01801. NDC# 48433-230-15
Lot/Code Info: Lot # 21A0073, Exp 11/30/2023; 21A0091, Exp. 12/31/2023; 21A0103, Exp 01/31/2024; 21A0135, Exp 03/31/2024; 22A0011, Exp 06/30/2024; 22A0019, Exp 07/31/2024; 22A0057, Exp 09/30/2024; 22A0083, Exp 11/30/2024; 22A0104, Exp 12/31/2024; 22A0110, Exp 01/31/2025; 22A0150, Exp 03/31/2025; 23A0007, Exp 06/30/2025; 23A0041, Exp 09/30/2025; 23A0045, Exp 11/30/2025; 23A0058, Exp 11/30/2025; 23A0067, Exp 11/30/2025; 23A0080, Exp 12/31/2025; 23A0090, Exp 01/31/2026
Quantity Affected: 166,022 bottles
Reason for Recall
CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
Distribution
Distributed Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-19
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 33 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-0082-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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