Reported Aug 7, 2019 · Terminated
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by…
Major Pharmaceuticals
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: MAJOR PHARMACEUTICALS · 17177 N Laurel Park Dr · Livonia, MI · 48152-2693
Is this the product you have?
- DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India
- Distributed by
Major Pharmaceuticals 17177 N Laurel Park DrSuite 233 LivoniaMI 48152. NDC # 0904-6363-61
- Lot codes and dates
- Lot# M02250 EXP 10/2020.
- Amount recalled
- 828 100-count unit dose cartons
Where it was sold
- Nationwide
Why it was recalled
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
This product could cause temporary or reversible health problems — stop using it.
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