Prescription ciprofloxacin eye drops recalled for temperature abuse manufacturing deviation
McKesson Medical-Surgical is recalling Ciprofloxacin Hydrochloride 0.3% ophthalmic solution nationwide due to temperature abuse, a cGMP violation that may compromise product integrity.
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 involving manufacturing deviations (cGMP temperature abuse) of a prescription drug. Although no illnesses or injuries have been reported, the manufacturing deviation presents a risk of compromised drug efficacy and safety. Score reflects potential risk without documented patient harm.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Ciprofloxacin Hydrochloride (Ciprofloxacin HCl) 0.3% ophthalmic solution in 5 mL bottles, a prescription antibiotic eye drop. The recall was initiated due to cGMP (current Good Manufacturing Practice) deviations involving temperature abuse. Approximately 7 bottles were distributed nationwide in the USA.
Temperature abuse is a manufacturing deviation that may affect the stability and integrity of the product. McKesson Medical-Surgical is unable to identify specific lot numbers for products received by individual customers. Each recall letter will include the dates the affected product may have been shipped to that customer.
Patients should contact their healthcare provider or pharmacy to determine if their supply is affected and discuss treatment options. Healthcare providers and distributors who received this product should verify their distribution records against recall information and follow all recall instructions provided by McKesson Medical-Surgical.
The recalled product
- Product
- CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE)
- Brand
- CIPROFLOXACIN HYDROCHLORIDE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 7
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (1)
- 0361314656100
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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