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Recall Observatory FDA recall evidence

Drug product

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

D-0141-2020

September 12, 2019

Class II

Product summary

Firm
Spectrum Laboratory Products
Event
Event 83796
Status
Terminated
Classification
Class II
Quantity
29.1 grams
Official record key
drug-enforcement:D-0141-2020

Official wording

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

Code information: Lot # 1HE0899, 1IB0005, Exp 02/28/2023

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

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations