D-0141-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 23, 2019
- Initiation Date
- September 12, 2019
- Termination Date
- November 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29.1 grams
Product Description
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 Pattern
Product was distributed to compounding pharmacies and labs in CA, CO, MD, SC.
Code Information
Lot # 1HE0899, 1IB0005, Exp 02/28/2023