Defective container:may contain bottles with incomplete seals
Drugs Recalls
Prescription and over-the-counter medications
Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 524103 0244 2.
Dabur India Limited
CGMP Deviations; deficiencies observed during FDA inspection
Labeling: Incorrect or Missing Lot and/or Exp Date
CGMP Deviations; deficiencies observed during FDA inspection
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
CGMP Deviations; deficiencies observed during FDA inspection
Crystallization; identified as Buprenorphine free base
Defective container:may contain bottles with incomplete seals
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 52924 00683 1.
Dabur India Limited
CGMP Deviations; deficiencies observed during FDA inspection
CGMP Deviations; deficiencies observed during FDA inspection
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propolis + Xylitol, 1 FL OZ (30 mL) per bottle, Manufactured For: Beekeeper's Naturals USA Inc., Covina, CA 91789.
BEEKEEPER'S NATURALS USA
Microbial Contamination of Non-Sterile Products
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
Microbial contamination of sterile products
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)
Fresenius Kabi USA
Failed Impurities/Degradations Specifications
Presence of Particulate matter: Particulate matter identified as glass.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit