Class II · Moderate risk Ongoing
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection
Reason Failed Stability Specifications
Sulfur Colloid Reaction Vial 1.0 mL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Processing Controls.
What was recalled
Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
- Recalling firm
- Synthetopes Inc
- Origin
- SC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1402-2019
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
Reason Subpotent drug
Class II · Moderate risk Terminated
Albuterol
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
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
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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