Recalls of acid reducers and stomach drugs - the class behind the ranitidine (Zantac) nitrosamine recalls.
209 recalls in this category, newest first.
Reason Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Reason Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and…
Reason Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and…
Reason Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Reason Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Reason Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during…
Reason Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during…
Reason Labeling: Not Elsewhere Classified - Wrong NDC number
Reason Subpotent Drug: Out of specification for assay
Reason Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Reason Failed pH Specifications
Reason Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18…
Reason Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Reason Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton…
Reason CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
Reason CGMP Deviations: Discoloration
Reason Lack of sterility assurance
Reason Lack of sterility assurance
Reason Discoloration
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Reason Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Reason Lack of assurance of sterility.
Reason cGMP deviations: Temperature abuse
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