Class II · Moderate risk
Sn-Pyrophosphate Kit
Lack of Processing Controls.
Sn-DTPA Kit 10 mg
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
Sn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.
- Recalling firm
- Synthetopes Inc
- Origin
- SC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1404-2019 · 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 recalls by Synthetopes Inc
All 2019 recalls
Class II · Moderate risk
Sn-Tetrofosmin Kit 5.0 mL
Lack of Processing Controls.
Class II · Moderate risk
Sn-d
Lack of Processing Controls.
Class II · Moderate risk
Sulfur Colloid Reaction Vial 1.0 mL
Lack of Processing Controls.
Other cgmp deviation recalls from 2019
All cgmp deviation recalls
Class II · Moderate risk
Yeast Arrest
cGMP violations
Class II · Moderate risk
Albuterol 2.5mg / Ipratropium 0.75mg/ Triamcinolone 0.5 mg 3ML Vial
Lack of Processing Controls
Class II · Moderate risk
Albuterol 1.25mg / Ipratropium 0.5mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 1.25mg / Ipratropium 0.5mg/ Budesonide 0.25mg
Lack of Processing Controls
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