DrugAug 3, 2022
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, 100-count blisters per recall — FDA D-1288-2022
FAILED DISSOLUTION SPECIFICATIONS
Class IIFDA: TerminatedDr. Reddy's Laboratories, Inc.
Complete FDA and NHTSA recall records dated in August 2022.
These records include useful source details for the selected month.
FAILED DISSOLUTION SPECIFICATIONS
Labeling: Missing label: Label missing from some prefilled pens.
Superpotent Drug: Out of specification assay result was obtained during stability testing.
Labeling: Missing label: the product tube was missing a label and contained a different formulation.
FAILED DISSOLUTION SPECIFICATIONS
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.