FDA-Drug2019-04-24Class II
Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, - 500 090 INDIA
Dr. Reddy's Laboratories, Inc.
Hazard
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Sold states
Product was distributed to major distributors and retailers who may have further distribute the product throughout the United States.
Affected count
33,958 bottles
Manufactured in
107 College Rd E, N/A, Princeton, NJ, United States
Products
Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, - 500 090 INDIA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1133-2019Don't want to check this manually?
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