FDA recall D-0141-2020

Product

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

Reason for recall

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

Distribution

Product was distributed to compounding pharmacies and labs in CA, CO, MD, SC.

Key facts

Status

Terminated

Initiation date

2019-09-12

Report date

2019-10-23

Termination date

2020-11-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gardena, CA, United States

Primary source

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