Class II · Moderate risk Terminated
Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compounding Pharmacy 1270 Don's Lane Conway, AR…
Reason Lack of assurance of sterility.
Is Ephedrine recalled?
89 FDA recalls mention Ephedrine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ephedrine.
Class II · Moderate risk Terminated
5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD Syringe Kit Check Tagged, PharMEDium…
Reason CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Class II · Moderate risk Terminated
ePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride, USP QS 10mL. 50 mg/10 mL (5 mg per mL). Volume 10 mL Single dose syringe…
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL Single dose syringe. Avella of Houston, 9265 Kirby…
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
ePHEDrine Sulfate, USP 50mg in 0.9% Sodium Chloride USP QS 10mL. 50 mg/10 mL (5 mg/mL). Volume: 10 mL. Single dose syringe…
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
ePHEDrine 50mg, 50 mg/10 mL (5 mg per mL) (Ephedrine Sulfate, USP 50mg in 0.9% Sodium Chloride, USPQS 10mL. 10 mL-Sterile use…
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
Ephedrine Sulfate Injection in all strengths, all doses, and all packaging.
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Ephedrine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe, Total Volume 10 mL, Rx only, SCA…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date.
Class II · Moderate risk Terminated
Maximum Strength Zephrex-D, Pseudoephedrine HCl, 30 mg, Nasal Decongestant. 24 softgel tablets per paper carton, Distributed by…
Reason Microbial Contamination of Non-Sterile Products
Class II · Moderate risk Terminated
ePHEDrine Sulfate In 0.9% Sodium Chloride, 5 mg per mL (50 mg per 10 mL), 10 mL Total Volume pre-filled syringes, packaged in a)…
Reason Subpotent Drug
Class II · Moderate risk Terminated
ePHEDrine sulfate 50 mg/10 ml syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St…
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321…
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Ephedrine Sulfate Injection Solution 1 mL, 50 mg/1 mL (50 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321…
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 25 mg/5 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321…
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Ephedrine Sulfate in 0.9% Sodium Chloride 10 mL, 50 mg/10 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321…
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
ePHEDrine Sulfate 5 mg/mL in NS 5 mL Fill in 12 mL Syringe (25 mg), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR…
Reason Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk Terminated
Ephedrine Sulfate 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 II · Moderate risk Terminated
Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton…
Reason Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Class II · Moderate risk Terminated
Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Vial (NDC: 69053-008-01); and b)…
Reason Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.
Class III · Low risk Terminated
Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles, Distributed by: Valeant…
Reason Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient…
Class II · Moderate risk Terminated
Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ephedrine Sulfate 5 mg/ml in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
ePHEDrine Sulfate PF (50 mg/10 mL), 10 mL Single-Use Syringe, For IV or IM Use Rx only, Compounded by US Compounding Pharmacy…
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
Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 25 mg/ 5mL, Rx only, PHARMAKON…
Reason Stability data does not support expiry.
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