Gordon Laboratories Recalls MONSEL'S Solution Due to Microbial Contamination
Gordon Laboratories is recalling 277 boxes of MONSEL'S (Ferric Subsulfate) Solution due to microbial contamination and high iron content.
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 and involves microbial contamination, which poses a significant risk of harm, meeting the criteria for a Severe rating.
Plain-English summary
Dercher Enterprises, Inc., DBA Gordon Laboratories, is recalling 277 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 affected product is identified by Batch # 579634 and 579635, with an expiration date of 5/2020.
The recall was initiated after FDA analysis revealed microbial contamination in the product. Additionally, the analysis found high out-of-specification results for iron content. The product was distributed nationwide in the USA.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on 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.
- Category
- Drug — Topical Antiseptic
- Affected units
- 277
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 (3)
- Batch #: 579634
- 579635
- Exp 5/2020
Distribution
Distributed nationwide across the United States.
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