Class II · Moderate risk Terminated
Streptomycin 24 mg/Dexamethasone 10 mg/mL Otic Injection, 1 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy…
Reason Lack of sterility assurance.
Is Dexamethasone recalled?
81 FDA recalls mention Dexamethasone. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Dexamethasone.
Class II · Moderate risk Terminated
Dexamethasone 24 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy, 310 Bluff City Hwy, Bristol, TN.
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
DEXAMETHASONE (NAPO4) 0.1% OPHTH* PRES-FREE SOLUTION, 10ml, Eye Drops, Professional Compounding Pharmacy, 996 NW Circle Blvd…
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Completed
OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator contained within carton, Rx only, Allergan…
Reason GMP Deviations: A silicone particulate was noted in Ozurdex.
Class II · Moderate risk Terminated
Dexamethasone 4 mg tablet NDC 49884-0087-01 28 days supply
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
Dexamethasone Sodium Phosphate added to 5% Dextrose in all strengths, all doses, and all packaging.
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Dexamethasone Sodium Phosphate in all strengths, all doses, and all packaging.
Reason Lack of sterility assurance.
Class III · Low risk Terminated
Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (NDC 0641-6146-01), packaged in 25 x 5 mL Vials…
Reason Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Class III · Low risk Terminated
Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in 25 x 1 mL Vials per shelf pack…
Reason Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Class II · Moderate risk Terminated
Dexamethasone Sodium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class III · Low risk Terminated
DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL, NDC…
Reason Failed Impurities/ Degradation Specifications
Class II · Moderate risk Terminated
Dexamethasone Sodium Phosphate 24 mg/mL (2.4%), Injectable, 2 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Dexamethasone Sodium Phosphate 200 mg/mL, Injectable, Compounded by Wells Pharmacy, Ocala, FL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Moxifloxacin 0.5% + Dexamethazone 0.1%, 15ml vial Contains: Moxifloxacin 5mg/ml, Dexamethasone Sodium Phosphate 1mg/ml, Rx only…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Dexamethasone Sodium Phosphate PF (10 mg/mL), 2 mL Single Use Vial, For IV or IM Use Only, Rx only, Compounded by US Compounding…
Reason Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an…
Class II · Moderate risk Terminated
Dex Combo (Dexamethasone acetate 8mg/mL, dexamethasone sodium phosphate USP, 4 mg/mL),30 mL Multi-Dose Vial, For IM & Regional…
Reason Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an…
Class II · Moderate risk Terminated
Dex LA 8 (Dexamethasone acetate (8 mg/mL), 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US…
Reason Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an…
Class II · Moderate risk Terminated
All Products Intended to be Sterile, mediStat Pharmacy, 110 East Azalea Ave., Foley, AL 36535, 844*737*2550. An Incomplete List…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Dexamethasone 0.4% Opth Ointment, 3.5 g ointment tubes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL…
Reason Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with…
Class II · Moderate risk Terminated
Dexamethasone 24 mg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Reason Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the…
Class II · Moderate risk Terminated
Dexamethasone 4 mg/mL Iontophoresis, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control…
Class II · Moderate risk Terminated
Dexamethasone Sodium Phosphate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Class II · Moderate risk Terminated
Dexamethasone Base active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Class II · Moderate risk Terminated
DEXAMETHASONE (AS SOD PHOS), 24 mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality…
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