Prescription eye ointment recalled for temperature storage deviations
McKesson Medical-Surgical recalls Neomycin and Polymyxin B Sulfates and Dexamethasone ophthalmic ointment (120 tubes) nationwide due to temperature storage deviations during manufacturing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for manufacturing deviations affecting a prescription ophthalmic medication. Temperature abuse of pharmaceuticals poses a potential risk to product stability and efficacy. No illnesses or injuries have been reported.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Neomycin and Polymyxin B Sulfates and Dexamethasone ophthalmic ointment in 3.5 g tubes (NDC 61314-631-36) due to Current Good Manufacturing Practice (cGMP) deviations involving temperature abuse during storage and distribution.
Temperature deviations can affect the stability and efficacy of pharmaceutical products. The medication was manufactured by Sandoz and distributed nationwide in the United States. McKesson Medical-Surgical cannot identify specific lot numbers for individual consignees; affected customers received separate notification letters with distribution dates and relevant shipment timeframes.
Healthcare providers and patients with this medication should contact their pharmacist or healthcare provider for guidance. Patients should not use the product if there is concern it was exposed to improper temperatures. Return the medication to your pharmacy for proper disposal.
This is an FDA Class II recall (D-1102-2022). For additional information, consult your healthcare provider or visit the FDA's drug recalls page at https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls.
The recalled product
- Product
- NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE)
- Brand
- NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Ophthalmic
- Hazard
- temperature-abuse
- manufacturing-deviation
Distribution
Distributed nationwide across the United States.
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