DMSO/VITAMIN C/GLUTATHIONE SOLUTION 6.25%/1.25%/1.25% OPHTHALMIC 10 ML, 15 ML, 5 ML (3 DIFFERENT PRODUCTS)
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-D-1508-2012.
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-D-1508-2012.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Franck's Lab Inc., D.b.a. Franck's Compounding Lab or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-D-1508-2012.
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Franck's Lab Inc., D.b.a. Franck's Compounding Lab Recall FAQ
Franck's Lab Inc., D.b.a. Franck's Compounding Lab is the subject of a supplements safety report: DMSO/VITAMIN C/GLUTATHIONE SOLUTION 6.25%/1.25%/1.25% OPHTHALMIC 10 ML, 15 ML, 5 ML (3 DIFFERENT PRODUCTS). The notice was published on May 25, 2012 by the U.S. Food and Drug Administration (FDA). Approximately 9 units are potentially affected.