Overview of recall records associated with Sun Pharmaceutical Industries, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 80, Class III: 32, Class I: 3.
Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
Presence of foreign substance
Discoloration
Presence of Foreign Substance
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
cGMP - Water leakage
CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification…
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
Failed Tablet/Capsule Specification; oversized tablet found in a bottle
Lack of assurance of sterility
Lack of assurance of sterility
Lack of assurance of sterility
Lack of assurance of sterility
Lack of assurance of sterility
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister…
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister…
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
This page summarizes recall records in which the official source identifies Sun Pharmaceutical Industries, 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.
