Triple Antibiotic Ointment Recalled Due to Improper Storage
McKesson Medical-Surgical Inc. is recalling Triple Antibiotic Ointment due to storage deviations that violated drug label specifications and current good manufacturing practices.
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: This is an FDA Class II recall involving improper storage of a pharmaceutical product, which creates a risk of harm through potential loss of product efficacy and stability. No illnesses or injuries have been reported, so the hazard remains theoretical.
Plain-English summary
Triple Antibiotic Ointment is being recalled by McKesson Medical-Surgical Inc. due to storage outside of the drug label specifications. The deviation from proper storage conditions represents a violation of current good manufacturing practice (CGMP) requirements.
The recalled product is Triple Antibiotic Ointment containing bacitracin zinc, neomycin sulfate, and polymyxin B sulfate, packaged in boxes of 144 packets with 0.5 grams per packet (NDC 0498-0750-36). The affected product is identified by part number 231209G. Six boxes of the affected product were distributed nationwide in the United States.
Improper storage of pharmaceutical products may compromise their integrity, stability, and efficacy. Consumers who have this product should consult their healthcare provider or pharmacist regarding use or replacement.
The recalled product
- Product
- Triple Antibiotic Ointment, Bacitracin zinc, Neomycin sulfate, Polymixin B sulfate, First Aid Antibiotic, Triple Antibiotic Ointment, 144 packets per box, Net wt. per packet 0.5 g, Honeywell Safety Products, NDC 0498-0750-36.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Topical Antibiotic
- Hazard
- improper-storage
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)
- Part# 231209G
Distribution
Distributed nationwide across the United States.
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