Class II · Moderate risk
Sodium Bicarbonate Powder
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Sodium Bicarbonate Powder
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Class II · Moderate risk
Sodium Bicarbonate Powder
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Class II · Moderate risk
Sodium Bicarbonate Powder
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Class II · Moderate risk
Sodium Bicarbonate Powder
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Class II · Moderate risk
VECURONIUM Bromide for Injection
CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a high out of specification impurity result was detected during routine quality testing of stability samples.
Class II · Moderate risk
Parsel Plus
Defective container: products are packaged in pouches which may not have been fully sealed
Class II · Moderate risk
No Doz
Defective container: products are packaged in pouches which may not have been fully sealed
Class II · Moderate risk
Excedrin Migraine
Defective container: products are packaged in pouches which may not have been fully sealed
Class II · Moderate risk
Excedrin Extra Strength
Defective container: products are packaged in pouches which may not have been fully sealed
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container.
Class II · Moderate risk
VersaPharm Incorporated
Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description testing for a surface defect of ink.
Class II · Moderate risk
Cleocin Phosphate
Presence of Particulate Matter: Firm is recalling a small number of vials with very small reflective flakes consistent with delamination of the glass vial.
Class II · Moderate risk
Cefazolin
Lack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injection, USP 1 gm vials, lot DB2208, due to a customer complaint for broken/cracked vials which was confirmed through review of retained samples.
Class II · Moderate risk
Actiq (oral transmucosal fentanyl citrate)
Failed Dissolution Specification; during stability testing
Class II · Moderate risk
Wydase 5ml
Lack of Assurance of Sterility
Class II · Moderate risk
Wydase 1ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Trypan Blue 0.15% 1ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Tri-Mix SS Pap 30mg
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Tri-Mix SS Pap 30mg
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Triamcinolone Acetonide 40mg/ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Triamcinolone 40mg PF 10ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Triamcinolone Diacetate 40mg 10ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Triamcinolone 40mg PF 10ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Triamcinolone PF 40mg 2ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.