Class II · Moderate risk Ongoing
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only…
Reason Failed Stability Specifications
Is Sulfur recalled?
18 FDA recalls mention Sulfur. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Sulfur.
Class III · Low risk Terminated
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC…
Reason Subpotent drug
Class II · Moderate risk Terminated
Albuterol (PF/SULFURIC ACID/DYE FREE) - 3ML tube - 0.083% Inhalation Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St…
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class III · Low risk Terminated
Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight 3.7 g each per carton,) Rx Only…
Reason Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
Class II · Moderate risk Terminated
Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser (sodium sulfacetamide 9.8% and sulfur 4.8%) Net Wt. 10 oz. (285 g) Rx Only NDC…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Sulfur Ointment 10%, Pomada de Azufre, 2.6 OZ (73.7g) jar; Manufactured by/ Fabricado por: De La Cruz Products, A Division of DLC…
Reason Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly placed on product.
Class II · Moderate risk Terminated
Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
SULFUR 5% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class III · Low risk Terminated
sulfur8 medicated LIGHT FORMULA (sulfur) anti-dandruff hair & scalp conditioner, 2%, packaged in a) 2 OZ (57g) jar (UPC 0 75610…
Reason Subpotent Drug: failed at the 3 and 6 month stability time points.
Class II · Moderate risk Terminated
Lipo-B MMC I (SULFUR FREE) Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America…
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk Terminated
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen, Rx Only, Sunscreen Broad Spectrum SPF 25, Net Wt. 3 oz (85 g)…
Reason Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
Class II · Moderate risk Terminated
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit, Rx Only, Sodium Sulfacetamide 9% and Sulfur 4.5% Wash, Net Wt. 16 oz (454 g)…
Reason Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
Class III · Low risk Terminated
sulfur8(R) medicated anti-dandruff conditioner, dandruff treatment for Braids, spray, Active Ingredient: Salicylic Acid, 2%, 12…
Reason Failed pH specification: Product pH test value of 5.72 failed to meet its product specification of 6.0 to 7.5.
Class II · Moderate risk Terminated
Mic Ultra-Sulfur Free 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Reason The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free…
Class II · Moderate risk Terminated
Mic Ultra-Sulfur Free 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Reason The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free…
Class II · Moderate risk Terminated
Mic Ultra 50ml- Sulfur Free w/Lido, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Reason The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free…
Class II · Moderate risk Terminated
Mic Ultra 50ml- Sulfur Free, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Reason The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free…
Class III · Low risk Terminated
Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC…
Reason Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.
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