FDA-Drug2019-10-23Class II

Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06

Spectrum Laboratory Products
Hazard

CGMP Deviations: Received notice from supplier that there is potential glass contamination.

Sold states
Product was distributed to compounding pharmacies and labs in CA, CO, MD, SC.
Affected count
29.1 grams
Manufactured in
14422 S San Pedro St, N/A, Gardena, CA, United States
Products
Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0141-2020

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