Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: product held outside appropriate storage temperature conditions.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
GOOD SENSE ESOMEPRAZOLE ACID REDUCER 20MG 42CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Drug: Esomeprazole Category: Heartburn & Stomach Medication
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Labeling: Not Elsewhere Classified - Wrong NDC number
Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
CGMP deviation: product outside labeled storage temperature requirements.
CGMP deviation: product outside labeled storage temperature requirements.
CGMP deviation: product outside labeled storage temperature requirements.
CGMP deviation: product outside labeled storage temperature requirements.
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