Reported Aug 9, 2017 · Terminated
Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count bottle (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, 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 byZydus Pharmaceuticals, Pennington, NJ 07054
- Lot codes and dates
124 of 124 codes
MR5990May-17MR5991May-17MR7294Jun-17MR7295Jun-17MR7296Jun-17MR7297Jun-17MR7298Jun-17MR7603Jun-17MR7604Jun-17MR7605Jun-17MR7606Jul-17MR7607Jul-17MR8575Aug-17MR8576Aug-17MR8577Aug-17MR8882Aug-17MR8883Aug-17MR8884Aug-17MR8885Aug-17MR8886Aug-17MR9417Aug-17MR9418Aug-17MR9419Aug-17MR9499Aug-17MR9500Aug-17MR9501Sep-17MR9502Sep-17MR9601Sep-17MR9602Sep-17MR9805Sep-17
- Amount recalled
- 115,122 HDPE bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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