GANCYCLOVIR, SDPF - (30G, 1/2" SYRINGE) 20MG/ML INJECTABLE 1 ML (1 PRODUCT)
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-D-1526-2012.
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-1526-2012.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-D-1526-2012.
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.
Visit FDA.gov →📣 Report an adverse event to the FDA (MedWatch)
If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or 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 an injectable drugs safety report: GANCYCLOVIR, SDPF - (30G, 1/2" SYRINGE) 20MG/ML INJECTABLE 1 ML (1 PRODUCT). The notice was published on May 25, 2012 by the U.S. Food and Drug Administration (FDA). Approximately 1 units are potentially affected.