Assured Naproxen Sodium Tablets Recalled Due to Mispackaging Error
Contract Packaging Resources Inc. is recalling Assured Naproxen Sodium Tablets because correct labeled bottles of Assured Ibuprofen softgels were mistakenly packaged into Naproxen cartons.
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, but the source text describes a mispackaging error without reporting any illnesses or injuries. Per the rubric, minor labeling/packaging errors without reported harm fall under Moderate severity.
Plain-English summary
Contract Packaging Resources Inc. is recalling Assured Naproxen Sodium Tablets, USP 220 mg., 15 count bottles. The recall is due to a mispackaging error where correct labeled bottles of Assured Ibuprofen softgels were packaged into cartons of Assured Naproxen Sodium Tablets.
The affected product is distributed by Greenbrier International, Inc. The recall involves 11,640 boxes distributed nationwide. The specific lot number is FH4102A, with UPC #639277223685 and an expiration date of 3/16.
Consumers should check their medication for this specific lot number and UPC. If they have the affected product, they should stop using it and contact the recalling firm or their healthcare provider for instructions on disposal or replacement.
The recalled product
- Product
- Assured Naproxen Sodium Tablets, USP 220 mg., 15 count bottle, Repackaged by Contract Packaging Resources, Inc 8009 Industrial Village Road Greensboro, NC 27409 Distributed by Greenbrier International, Inc Chesapeake, VA 23320
- Manufacturer
- Contract Packaging Resources Inc.
- Affected units
- 11,640
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 FH4102A UPC #639277223685
- Exp. Date 3/16
Distribution
Distributed nationwide across the United States.
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