Class II · Moderate risk
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection
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.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
Drug: Sulfur
- Recalling firm
- Synthetopes Inc
- Origin
- SC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1402-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Sulfur recalls
See all
Class III · Low risk
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser
Subpotent drug
Class II · Moderate risk
Albuterol (Pf/Sulfuric Acid/Dye Free)
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class III · Low risk
Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads
Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
Class II · Moderate risk
Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Other recalls by Synthetopes Inc
All 2019 recalls
Class II · Moderate risk
Sn-Pyrophosphate Kit
Lack of Processing Controls.
Class II · Moderate risk
Sn-Tetrofosmin Kit 5.0 mL
Lack of Processing Controls.
Class II · Moderate risk
Sn-DTPA Kit 10 mg
Lack of Processing Controls.
Class II · Moderate risk
Sn-d
Lack of Processing Controls.
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