Gordon Laboratories Recalls Monsel's Solution Due to High Iron Levels
Gordon Laboratories is recalling specific batches of Monsel's (Ferric Subsulfate) Solution because they contain higher levels of iron than labeled.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score per the rubric, as it involves a potential health risk that may cause temporary or medically reversible adverse health consequences.
Plain-English summary
Gordon Laboratories is recalling 1,155 boxes of Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottles. The product is packaged as one dozen bottles with applicators per box and is available by prescription only. The recall covers specific batches with expiration dates of 12/18 and 04/19.
The recall was initiated because the affected product is a superpotent drug that contains higher levels of iron than labeled. This discrepancy in iron content poses a potential risk to patients using the medication.
The affected product was distributed nationwide in the USA. Patients and healthcare providers should check their inventory for the specific batch numbers and expiration dates listed in the recall notice. If the product is found, it should be stopped and returned to the pharmacy or supplier for disposal or replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Gordon Laboratories
- Category
- Drug — Prescription Medication
- Affected units
- 1,155
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Batch #: 579602
- 579604
- 579606
- Exp 12/18
- 579609
- Exp 04/19.
Distribution
Distributed nationwide across the United States.
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