CLASS II Drug recall · Reported 19 Nov 2014 · FDA Enforcement Report
Assured Naproxen Sodium Tablets, USP 220 mg recalled
Contract Packaging Resources is recalling Assured Naproxen Sodium Tablets, USP 220 mg, distributed nationwide in the US. The recall was initiated on 10 Oct 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0248-2015
- FDA event ID
- 69554
- Recalling firm
- Contract Packaging Resources, Greensboro, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Oct 2014
- FDA classified
- 13 Nov 2014
- Reported
- 19 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 10 Oct 2014 | Recall initiated by company | |
| 13 Nov 2014 | Classified by FDA | +34 days |
| 19 Nov 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Correct Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were packaged into cartons of Assured Naproxen Sodium Tablets, USP
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Is Assured Naproxen Sodium Tablets, USP 220 mg recalled?
Yes. Contract Packaging Resources recalled Assured Naproxen Sodium Tablets, USP 220 mg on 10 Oct 2014. The recall is Class II and its status is Terminated. Recall number D-0248-2015.
Why was it recalled?
Correct Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were packaged into cartons of Assured Naproxen Sodium Tablets, USP
Which lots are affected?
Lot FH4102A UPC #639277223685, Exp. Date 3/16
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.