FDA Drug recall D-0889-2018
fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 5…
- FDA Drug
- Class II
- terminated
- Published 2018-07-04
On 2018-07-04 the FDA classified a Class II recall of fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 5… by Advanced Pharma, citing subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0889-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-20 |
| Published | 2018-07-04 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Advanced Pharma |
| Distribution | TX |
Product
fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B Outsourcing Facility 9265 Kirby Dr., Houston, TX 77054, NDC 15082-210-72.
Reason
Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.
Identifiers
| code_info | Lot #: 6/12/18 0432 149-21072S, BUD 9/10/18 |
|---|
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-0889-2018%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.