Overview of recall records associated with Zydus Pharmaceuticals USA Inc., including dates, categories and classifications where available.
Classification mix: Class II: 60, Class III: 13, Class I: 3.
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a…
Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets
Failed Dissolution Specifications; 9 month long term stability
Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
Failed Dissolution Specifications; 6 month time point
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability…
Failed Dissolution Specifications: out of specification dissolution results in retained samples
Failed Dissolution Specifications: out of specification dissolution results in retained samples
Failed Impurities/Degradation Specifications: Out of specification for a known degradant.
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.
Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.
This page summarizes recall records in which the official source identifies Zydus Pharmaceuticals USA 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.
