Class I - Dangerous
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Morphine Sulfate 15mg/ml Injection, 20 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS
Pharmacy Plus, Inc.
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Class I - Dangerous
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Class I - Dangerous
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60
Reckitt Benckiser
Class I - Dangerous
Labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydramine 25 mg instead of 12.5 mg. Also, quantity is incorrectly stated as 30 daytime and 30 nighttime instead of 36 daytime and 24 nighttime.
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Expiration Date
Class I - Dangerous
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class I - Dangerous
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Mozobil (plerixafor injection) 24 mg/1.2 mL (20 mg/mL) per vial, Rx Only, For Subcutaneous Injection only, Manufactured by: Genzyme Corporation, 500 Kendall Street, Cambridge, MA 02142 A Sanofi Company Country of Origin : United Kingdom, NDC 0024-5862-01
Genzyme Corporation / Genzyme Biosurgery
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Class I - Dangerous
Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab 4mg) in the product bottle of Pantoprazole.