CVS Triple Antibiotic Ointment Spray Recalled for Low Bacitracin Zinc Levels
Product Quest Manufacturing LLC is recalling CVS Health Triple Antibiotic Ointment Spray because the bacitracin zinc ingredient was found to be subpotent.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a subpotent drug (low potency) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Product Quest Manufacturing LLC is recalling 11,016 cans of CVS Health, Original Strength, Triple Antibiotic Ointment Spray. The product is a 2 OZ (57 g) can containing bacitracin zinc, neomycin sulfate, and polymyxin B sulfate. The recall is due to low out-of-specification assay results for the bacitracin zinc ingredient, making the drug subpotent.
The affected product is identified by Lot 170591E and an expiration date of 11/17/18. It was distributed nationwide in the USA by CVS Pharmacy, Inc. The product is identified by Product#957603 and UPC 0 50428 29525 0.
Consumers should check their inventory for this specific lot number and expiration date. If they have the affected product, they should stop using it and follow instructions from the recalling firm or their healthcare provider regarding disposal or return.
The recalled product
- Product
- CVS Health, Original Strength, Triple Antibiotic Ointment Spray (bacitracin zinc 400 units, neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units per gram), 2 OZ (57 g) can, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Product#957603, UPC 0 50428…
- Manufacturer
- Product Quest Manufacturing LLC
- Category
- Drug — Topical Antibiotic
- Hazard
- Affected units
- 11,016
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 (2)
- Lot: 170591E
- Exp. 11/17/18
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 54 recalled by Product Quest Manufacturing LLC 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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