Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
Zydus Pharmaceuticals (USA)
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Failed Impurity/Degradation Specifications
Failed Impurity/Degradation Specifications
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Labeling: Not Elsewhere Classified - Wrong NDC number
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Class I - Dangerous
Presence of particulate matter: glass
Cross contamination with other products.
Cross contamination with other products.
Cross contamination with other products
Cross contamination with other products
Failed Impurities/Degradation Specifications.
Failed Impurities/Degradation Specifications.
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Failed Dissolution Specifications
Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine.
Failed Impurities/Degradation Specifications
Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
Crystallization: customer complaints for crystallization in finished product.
Crystallization: customer complaints for crystallization in finished product.
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specification
Failed Dissolution Specification
cGMP Deviations
Class I - Dangerous
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.
Class I - Dangerous
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class I - Dangerous
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class I - Dangerous
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.
Class I - Dangerous
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class I - Dangerous
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 bottle of Carvedilol tablets 3.125mg.
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
Failed Dissolution Specifications
Failed Dissolution Specifications
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 samples of two batches.
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.
Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.
Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle.
Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that several tablets displayed brown specks. The same complainant also reported that metal shaving like material was observed on the surface of one tablet.