Class II · Moderate risk
Pantoprazole Sodium in 0.9% Sodium Chloride Injection
CGMP Deviations
Heartburn & Stomach Medication Recalls
Recalls of acid reducers and stomach drugs - the class behind the ranitidine (Zantac) nitrosamine recalls.
211 recalls in this category, newest first.
Class II · Moderate risk
Famotidine Injection in Sodium Chloride Injection
CGMP Deviations
Class II · Moderate risk
Pantoprazole Sodium
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Class II · Moderate risk
Ondansetron Orally Disintegrating Tablets
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Class II · Moderate risk
Ondansetron ODT Tablets
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Class I · High risk
Famotidine Injection
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Class II · Moderate risk
Omeprazole Delayed-release Capsules
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Class II · Moderate risk
Esomeprazole Magnesium for Delayed-Release Oral Suspension
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Class II · Moderate risk
Esomeprazole Magnesium for Delayed-Release Oral Suspension
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Class III · Low risk
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg
Labeling: Not Elsewhere Classified - Wrong NDC number
Class II · Moderate risk
Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1
Subpotent Drug: Out of specification for assay
Class II · Moderate risk
Ibuprofen and Famotidine Tablets 800mg/26.6mg
Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Class II · Moderate risk
Ondansetron Injection
Failed pH Specifications
Class III · Low risk
Esomeprazole Magnesium Delayed-Release Capsules
Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).
Class II · Moderate risk
Pantoprazole Sodium for Injection 40mg per vial
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Class II · Moderate risk
Famotidine Tablets
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 indicating strength as 10 mg.
Class II · Moderate risk
Pantoprazole sodium for Injection 40 mg*/vial
CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
Class II · Moderate risk
Pantoprazole Sodium Delayed Release Tablets USP 40mg
CGMP Deviations: Discoloration
Class II · Moderate risk
Pantoprazole 30mg in Ns 7.5ml
Lack of sterility assurance
Class II · Moderate risk
Ondansetron 8mg in Ns 100ml
Lack of sterility assurance
Class II · Moderate risk
Class II · Moderate risk
GOOD SENSE ESOMEPRAZOLE ACID REDUCER 20MG 42CT distributed to…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Good Sense Omeprazole Tablet 14ct Sku 900055 Prilosec OTC…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class III · Low risk
Esomeprazole Magnesium Delayed-Release Capsules
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Class III · Low risk
Esomeprazole Magnesium Delayed-Release Capsules
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
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