Synthetopes Inc recalls Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
- Recall date
- May 28, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1402-2019
- FDA classification
- Class II
- Brand / firm
- Synthetopes Inc
- Sold / distributed
- Nationwide.
Why it was recalled
Lack of Processing Controls.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
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