CLASS II Drug recall · Reported 4 Jul 2018 · FDA Enforcement Report
fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride recalled
Advanced Pharma is recalling fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP, 10 mcg per mL prefilled syringe, distributed in Texas. The recall was initiated on 20 Jun 2018 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-0889-2018
- FDA event ID
- 80354
- Recalling firm
- Advanced Pharma, Houston, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Jun 2018
- FDA classified
- 25 Jun 2018
- Reported
- 4 Jul 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 20 Jun 2018 | Recall initiated by company | |
| 25 Jun 2018 | Classified by FDA | +5 days |
| 4 Jul 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Distributed to one medical center in Fort Worth, TX.
Questions about this recall
Why was it recalled?
Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.
Which lots are affected?
Lot #: 6/12/18 0432 149-21072S, BUD 9/10/18
Where was it sold?
Distributed to one medical center in Fort Worth, TX.
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 |