Why it was recalled
Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.
Product description
Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only, Manufactured by Upsher-Smith Laboratories, Inc., Minneapolis, MN 55447, NDC 0245-0182-11.
Lot numbers, UPCs & expiration codes
Lot #: 310162, Exp 09/14
Where it was sold
Nationwide and Puerto Rico
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-127-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 10, 2012
- FDA report date
- Jan 23, 2013
- Quantity
- 11,316 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Upsher Smith Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-127-2013, exactly as published.
Show all FDA fields
- City
- Maple Grove
- State
- MN
- Status
- Terminated
- Country
- United States
- Event ID
- 64085
- Address
- 6701 Evenstad Drive
- Code information
- Lot #: 310162, Exp 09/14
- Postal code
- 55369
- Report date
- Jan 23, 2013
- Product type
- Drugs
- Recall number
- D-127-2013
- Classification
- Class III
- Recalling firm
- Upsher Smith Laboratories, Inc.
- Product quantity
- 11,316 bottles
- Termination date
- Nov 19, 2013
- Reason for recall
- Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only, Manufactured by Upsher-Smith Laboratories, Inc., Minneapolis, MN 55447, NDC 0245-0182-11.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Dec 10, 2012
- Initial firm notification
- Telephone
- Center classification date
- Jan 16, 2013