Edge Pharma Recalls Methotrexate Syringes Due to Sterility Testing Concerns
Edge Pharma, LLC is recalling 71 syringes of Methotrexate USP Sterile Solution for Injection because the media used for post-compounding sterility testing was expired.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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. According to the rubric, an FDA Class II recall involving a sterile injectable product where sterility assurance is compromised is categorized as Severe (Score 4).
Plain-English summary
Edge Pharma, LLC is recalling 71 syringes of Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml). The product is identified by Lot# 01-2020-28@10 and was distributed nationwide.
The recall was initiated due to a lack of assurance of sterility. The media used to conduct post-compounding sterility testing for the Methotrexate product was expired, which means the sterility of the product cannot be fully verified.
Healthcare providers and patients should stop using the affected product and contact Edge Pharma, LLC at 1-802-992-1178 for further instructions.
The recalled product
- Product
- Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only, SYRINGE FOR IM INJECTION, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178, Barcode 0544650505
- Manufacturer
- Edge Pharma, LLC
- Hazard
- Affected units
- 71
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 (1)
- Lot# 01-2020-28@10
Distribution
Distributed nationwide across the United States.
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