Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: product held outside appropriate storage temperature conditions.
GOOD SENSE OMEPRAZOLE TABLET 14CT SKU 900055 PRILOSEC OTC TABLET 14 CT SKU914128 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
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 Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
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
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