CLASS II Drug recall · Reported 27 Feb 2019 · FDA Enforcement Report
Fentanyl in 0.9% Sodium Chloride QS, 5 mcg recalled by Advanced Pharma
Advanced Pharma is recalling Fentanyl in 0.9% Sodium Chloride QS, 5 mcg/ with up to of overfill Injectable Solution, distributed in Pennsylvania. The recall was initiated on 6 Feb 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0496-2019
- FDA event ID
- 82130
- Recalling firm
- Advanced Pharma, Houston, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Feb 2019
- FDA classified
- 15 Feb 2019
- Reported
- 27 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 6 Feb 2019 | Recall initiated by company | |
| 15 Feb 2019 | Classified by FDA | +9 days |
| 27 Feb 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect expiration date.
Product as listed by the FDA
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
Where it was distributed
PA
Questions about this recall
Why was it recalled?
Labeling: Incorrect expiration date.
Which lots are affected?
Lot#: 12/31/18 0555 21072S, Exp 3/31/2019
Where was it sold?
PA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Advanced Pharma
All 99| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | HYDROmorphone 20 mg/ Injectable Solution recalled by Advanced Pharma | Advanced Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Neostigmine Methylsulfate Injection Solution 5 mg recalled | Advanced Pharma | Sterility | Nationwide |
| Drug | CLASS II | Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride recalled | Advanced Pharma | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride recalled | Advanced Pharma | Sterility | Nationwide |
| Drug | CLASS II | Heparin in 0.45% Sodium Chloride, QS, Injectable Solution recalled | Advanced Pharma | Sterility | Nationwide |
Other Fentanyl recalls
All 248| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | fentaNYL Citrate, 1,000 mcg recalled by OurPharma | OurPharma | Other | Nationwide |
| Drug | CLASS II | fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg recalled | IntegraDose Compounding Services | Potency & Assay | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution recalled by Wells Pharma of Houston | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution, Narcotic, CII recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution, Narcotic, Cii recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |