EZETIMIBE AND SIMVASTATIN Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 recall — FDA D-0084-2022
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Overview of recall records associated with Dr. Reddy's Laboratories, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 50, Class III: 33, Class I: 3.
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin…
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
Failed Dissolution Specifications
Defective Container: Recall is due to breaking and shattering of ampules upon opening
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
This page summarizes recall records in which the official source identifies Dr. Reddy's Laboratories, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.