Class I - Dangerous
Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
Jubilant Cadista Pharmaceuticals
Failed Dissolution Specifications
Failed dissolution specifications.
Class I - Dangerous
Subpotent
Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride
Subpotent
Failed Dissolution Specifications
Class I - Dangerous
Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.
Class I - Dangerous
Failed Tablet/Capsule Specification
Subpotent
Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
Class I - Dangerous
CGMP Deviations: Presence of dark brown discoloration on edges of tablets
Presence of Foreign Substance: Presence of a foreign object in a single tablet.
CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
Failed dissolution specifications : failed results at the 3-month stability time point.
Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.
Failed Dissolution Specifications; 9-monthstability timepoint
Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.
Class I - Dangerous
Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
Class I - Dangerous
Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is printed on the container label instead of the correct expiration date of 02/2018.
Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.
cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.