Reported Apr 5, 2017 · Terminated
Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC…
Zydus Pharmaceuticals USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zydus Pharmaceuticals USA Inc · 73 Route 31 N · Pennington, NJ · 08534-3601
Is this the product you have?
- Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India
- Distributed byZydus Pharmaceuticals, Pennington, NJ
- Lot codes and dates
11 of 11 products
Products covered by this recall # Product as published 1 MR8221, MR8222 exp 7/31/2017 2 MR10260, exp 9/30/2017 3 MR10926, exp 10/31/2017 4 MR6187, exp 5/31/2017 5 MR7302, exp 6/30/2017 6 MR7768, MR7769, exp 7/31/2017 7 MR8247, exp 7/31/2017 8 MR8887, MR8892, MR8893 exp 8/31/2017 9 MR9014, MR10414 exp 9/30/2017 10 MR10928, exp 10/31/2017 11 MR11183, MR11185, MR11186, exp 11/30/2017 - Amount recalled
- 32628 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications; 9 month long term stability
This product could cause temporary or reversible health problems — stop using it.
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