Edge Pharma Recalls Ceftazidime Sterile Ophthalmic Solution Due to Sterility Concerns
Edge Pharma, LLC is recalling 48 syringes of Ceftazidime Sterile Ophthalmic Solution because the media used for sterility testing was expired, compromising the assurance of sterility.
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, and the hazard involves a lack of assurance of sterility for a product intended for intraocular injection, which poses a significant risk of serious injury or hospitalization if contaminated.
Plain-English summary
Edge Pharma, LLC is recalling 48 syringes of Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (22.5mg/ml). The product is a compounded drug intended for intraocular injection and was distributed nationwide in the USA.
The recall was initiated due to a lack of assurance of sterility. The source text notes that the media used to conduct post-compounding sterility testing for the Methotrexate product was expired. This expired media compromises the validity of the sterility testing results for the affected lot.
Healthcare facilities and patients who have received this product should stop using it and contact their healthcare provider or Edge Pharma, LLC for further instructions. The product is not for resale and is intended for hospital or office use only.
The recalled product
- Product
- Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (22.5mg/ml) 0.5ml per syringe. KEEP FROZEN UNTIL USE AND PROTECT FROM LIGHT SINGLE USE SYRINGE FOR INTRAOCULAR INJECTION Edge Pharma, LLC is an FDA-registered 503B outsourcing facility. This…
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Ophthalmic Solution
- Affected units
- 48
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 # 02-2020-04@4
Distribution
Distributed nationwide across the United States.
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