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High RiskFDAfda-D-1508-2012STERILITY ISSUE

DMSO/VITAMIN C/GLUTATHIONE SOLUTION 6.25%/1.25%/1.25% OPHTHALMIC 10 ML, 15 ML, 5 ML (3 DIFFERENT PRODUCTS)

Category
Units Affected
9
Recall Date
May 25, 2012
Issuing Agency
Hazard
Sterility Issue

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

  1. Stop using the product if you own it.
  2. Check the model number, lot code, or sell-by date against the recall notice above.
  3. 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.
  4. For the most current official instructions, visit the FDA recall page.
  5. 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

FDA

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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.