Why it was recalled
Correct Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were packaged into cartons of Assured Naproxen Sodium Tablets, USP
Product description
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
Lot numbers, UPCs & expiration codes
Lot FH4102A UPC #639277223685, Exp. Date 3/16
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0248-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 10, 2014
- FDA report date
- Nov 19, 2014
- Quantity
- 11,640 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Contract Packaging Resources Inc.
Original FDA data
Every field from FDA enforcement report D-0248-2015, exactly as published.
Show all FDA fields
- City
- Greensboro
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 69554
- Address
- 8009 Industrial Village Rd
- Code information
- Lot FH4102A UPC #639277223685, Exp. Date 3/16
- Postal code
- 27409-9604
- Report date
- Nov 19, 2014
- Product type
- Drugs
- Recall number
- D-0248-2015
- Classification
- Class II
- Recalling firm
- Contract Packaging Resources Inc.
- Product quantity
- 11,640 boxes
- Termination date
- Jan 5, 2016
- Reason for recall
- Correct Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were packaged into cartons of Assured Naproxen Sodium Tablets, USP
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 10, 2014
- Initial firm notification
- Telephone
- Center classification date
- Nov 13, 2014