D-0141-2020 Class II Terminated
FDA drug recall D-0141-2020 was initiated by Spectrum Laboratory Products on Sep 12, 2019 and is designated Class II. Reason for recall: CGMP Deviations: Received notice from supplier that there is potential glass contamination. The recall status is terminated (terminated Nov 10, 2020). Affected quantity: 29.1 grams.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 23, 2019
- Initiation Date
- Sep 12, 2019
- Termination Date
- Nov 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0141-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026