Vi-Jon Magnesium Citrate Oral Solution Cherry Flavor, 1.745 g per fl oz recall — FDA D-0006-2018
Failed Impurities/Degradation Specifications.
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
10,690 detailed records are currently available in this category.
Failed Impurities/Degradation Specifications.
Failed Impurities/Degradation Specifications.
Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.
Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is printed on the product labeling rather than the correct expiration date of July 2017.
Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.
Crystallization: Product is being recalled due to the manufacturer's recall due to the presence of visible particulate in vials that has been identified as crystalline ketorolac calcium…
Failed Dissolution Specifications
Failed Dissolution Specifications
CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compounding Use.
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.
Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.
Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.
Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test
Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil and tadalafil
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