17 FDA recalls mention Esomeprazole. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Esomeprazole.
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 CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Reason Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Reason Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Reason Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Reason Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Reason Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Reason Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Reason Discoloration: product contains brown pellets
Reason Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
Reason Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an unopened bottle labeled as NEXIUM¿ capsules…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market…
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