Reported Jul 31, 2019 · Terminated
MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box,…
Dercher Enterprises, Inc., dba Gordon Laboratories
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dercher Enterprises, Inc., DBA Gordon Laboratories · 6801 Ludlow St · Upper Darby, PA · 19082-2408
Is this the product you have?
- MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8.
- Lot codes and dates
Batch #: 579634579635Exp 5/2020
- Amount recalled
- 277 boxes
Where it was sold
- Nationwide
Why it was recalled
Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of specification results for iron content.
This product could cause temporary or reversible health problems — stop using it.
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