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.
Other recalls by Advanced Pharma
- HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% Sodium Chloride 100 mL, Sterile single use bag, Compounded Dru…
FDA Drug · Class II · 2019-05-08 · Advanced Pharma - Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile single use syringe, For IV or IM use, NDC: 42852-828-22 Avella…
FDA Drug · Class II · 2019-03-27 · Advanced Pharma - 2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL), 5mL Sterile single use syringe, NDC: 42852-011-67 Avella of Houston 9265…
FDA Drug · Class II · 2019-03-27 · Advanced Pharma - Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units in 0.9% Sodium Chloride, QS 5 mL Sterile single use syringe,…
FDA Drug · Class II · 2019-03-27 · Advanced Pharma - Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 400 mcg/10 mL (40 mcg per mL), Sterile single use syringe,…
FDA Drug · Class II · 2019-03-27 · Advanced Pharma
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.