Drug product
Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06
D-0141-2020
Product summary
- 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
CGMP Deviations