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.
Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets, USP, 50 mg
Subpotent and Presence of Particulates .
Presence of foreign substance: identified as activated carbon.
Microbial Contamination of Non-Sterile Product
Failed Moisture Limits: Out of specification for water content
CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in…
Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.
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.
