FDA Drug recall D-0496-2019
Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of overfill Injectable Solution, Sterile single use syringe, Rx…
- FDA Drug
- Class II
- terminated
- Published 2019-02-27
On 2019-02-27 the FDA classified a Class II recall of Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of overfill Injectable Solution, Sterile single use syringe, Rx… by Advanced Pharma, citing labeling: Incorrect expiration date.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0496-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-02-06 |
| Published | 2019-02-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Advanced Pharma |
| Distribution | PA |
Product
Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of overfill Injectable Solution, Sterile single use syringe, Rx only, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404, NDC 42852-210-72
Reason
Labeling: Incorrect expiration date.
Identifiers
| code_info | Lot#: 12/31/18 0555 21072S, Exp 3/31/2019 |
|---|
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-0496-2019%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.