Fentanyl Citrate USP recalled over manufacturing violations
- Recall date
- September 12, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Spectrum Laboratory Products recalls Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-…
- Recall number
- D-0141-2020
- FDA classification
- Class II
- Brand / firm
- Spectrum Laboratory Products
- Sold / distributed
- Product was distributed to compounding pharmacies and labs in CA, CO, MD, SC.
Why it was recalled
CGMP Deviations: Received notice from supplier that there is potential glass contamination.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06
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