FDA Drug recall D-0141-2020
Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06
- FDA Drug
- Class II
- terminated
- Published 2019-10-23
On 2019-10-23 the FDA classified a Class II recall of Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06 by Spectrum Laboratory Products, citing CGMP Deviations: Received notice from supplier that there is potential glass contamination.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0141-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-12 |
| Published | 2019-10-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Spectrum Laboratory Products |
| Distribution | CA, CO, MD, SC |
Product
Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06
Reason
CGMP Deviations: Received notice from supplier that there is potential glass contamination.
Identifiers
| code_info | Lot # 1HE0899, 1IB0005, Exp 02/28/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0141-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.