Why it was recalled
Failed Dissolution Specifications
Product description
Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count bottle (NDC 68382-032-05),Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054
Lot numbers, UPCs & expiration codes
MR5990 May-17 MR5991 May-17 MR7294 Jun-17 MR7295 Jun-17 MR7296 Jun-17 MR7297 Jun-17 MR7298 Jun-17 MR7603 Jun-17 MR7604 Jun-17 MR7605 Jun-17 MR7606 Jul-17 MR7607 Jul-17 MR8575 Aug-17 MR8576 Aug-17 MR8577 Aug-17 MR8882 Aug-17 MR8883 Aug-17 MR8884 Aug-17 MR8885 Aug-17 MR8886 Aug-17 MR9417 Aug-17 MR9418 Aug-17 MR9419 Aug-17 MR9499 Aug-17 MR9500 Aug-17 MR9501 Sep-17 MR9502 Sep-17 MR9601 Sep-17 MR9602 Sep-17 MR9805 Sep-17 MR9806 Sep-17 MR9807 Sep-17 MR9808 Sep-17 MR10536 Oct-17 MR10537 Oct-17 MR10538 Oct-17 MR10539 Oct-17 MR10540 Oct-17 MR10916 Oct-17 MR10918 Oct-17 MR10919 Nov-17 MR10920 Nov-17 MR10921 Nov-17 MR11366 Nov-17 MR11367 Nov-17 MR11368 Nov-17 MR11369 Nov-17 MR11370 Nov-17 MR11671 Nov-17 MR11672 Nov-17 MR11682 Nov-17 MR11682 Nov-17 MS1360 Dec-17 MS1361 Dec-17 MS1362 Dec-17 MS1363 Dec-17 MS1364 Dec-17 M600386 Feb-18 M600387 Feb-18 M600388 Feb-18 M602270 Mar-18 M602272 Apr-18
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-1042-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 10, 2017
- FDA report date
- Aug 9, 2017
- Quantity
- 115,122 HDPE bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-1042-2017, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 77674
- Address
- 73 Route 31 N
- Code information
- MR5990 May-17 MR5991 May-17 MR7294 Jun-17 MR7295 Jun-17 MR7296 Jun-17 MR7297 Jun-17 MR7298 Jun-17 MR7603 Jun-17 MR7604 Jun-17 MR7605 Jun-17 MR7606 Jul-17 MR7607 Jul-17 MR8575 Aug-17 MR8576 Aug-17 MR8577 Aug-17 MR8882 Aug-17 MR8883 Aug-17 MR8884 Aug-17 MR8885 Aug-17 MR8886 Aug-17 MR9417 Aug-17 MR9418 Aug-17 MR9419 Aug-17 MR9499 Aug-17 MR9500 Aug-17 MR9501 Sep-17 MR9502 Sep-17 MR9601 Sep-17 MR9602 Sep-17 MR9805 Sep-17 MR9806 Sep-17 MR9807 Sep-17 MR9808 Sep-17 MR10536 Oct-17 MR10537 Oct-17 MR10538 Oct-17 MR10539 Oct-17 MR10540 Oct-17 MR10916 Oct-17 MR10918 Oct-17 MR10919 Nov-17 MR10920 Nov-17 MR10921 Nov-17 MR11366 Nov-17 MR11367 Nov-17 MR11368 Nov-17 MR11369 Nov-17 MR11370 Nov-17 MR11671 Nov-17 MR11672 Nov-17 MR11682 Nov-17 MR11682 Nov-17 MS1360 Dec-17 MS1361 Dec-17 MS1362 Dec-17 MS1363 Dec-17 MS1364 Dec-17 M600386 Feb-18 M600387 Feb-18 M600388 Feb-18 M602270 Mar-18 M602272 Apr-18
- Postal code
- 08534-3601
- Report date
- Aug 9, 2017
- Product type
- Drugs
- Recall number
- D-1042-2017
- Classification
- Class II
- Recalling firm
- Zydus Pharmaceuticals USA Inc
- Product quantity
- 115,122 HDPE bottles
- Termination date
- Jan 7, 2020
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count bottle (NDC 68382-032-05),Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054
- Distribution pattern
- Nationwide
- Recall initiation date
- May 10, 2017
- Initial firm notification
- Letter
- Center classification date
- Jul 31, 2017