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

FDA recall notice · announced October 23, 2019 · Spectrum Laboratory Products

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Product was distributed to compounding pharmacies and labs in CA, CO, MD, SC.
Lot/code information: Lot # 1HE0899, 1IB0005, Exp 02/28/2023
Quantity: 29.1 grams
Status: Terminated
Products in this recall event:
- Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06 (D-0141-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.