Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands, NDC 82009-022-10. NDC 82009-022-10
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during…
Reason Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during…
Reason Labeling: Not Elsewhere Classified - Wrong NDC number
Reason Subpotent Drug: Out of specification for assay
Reason Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18…
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