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
Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.
What was recalled
Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC, Wilmington, DE
- Recalling firm
- Mission Pharmacal Co
- NDC code
- 42792-102-01
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-602-2013
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Sulfur recalls
See all
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.
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