Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: product held outside appropriate storage temperature conditions.
GOOD SENSE ESOMEPRAZOLE ACID REDUCER 20MG 42CT 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 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 Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18…
Reason Superpotent Drug: Out of specification for assay at the 12-month timepoint.
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