CLASS II Drug recall · Reported 8 Jun 2022 · FDA Enforcement Report
Fentanyl Citrate in 0.9% Sodium Chloride Injection recalled
Nephron Sterile Compounding Center is recalling Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/ (10 mcg/mL) IV, IV, distributed nationwide in the US. The recall was initiated on 18 May 2022 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-0954-2022
- FDA event ID
- 90211
- Recalling firm
- Nephron Sterile Compounding Center, West Columbia, SC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 May 2022
- FDA classified
- 27 May 2022
- Reported
- 8 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 18 May 2022 | Recall initiated by company | |
| 27 May 2022 | Classified by FDA | +9 days |
| 8 Jun 2022 | 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
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL), 150 mL IV Bag, 10 x 1 IV Bag, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lots: FN1088A, Exp. 6/21/2022; FN1089A, Exp. 6/26/2022
Where was it sold?
Nationwide in the USA
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.
Other products in this recall event
19 other products · FDA event 90211This product is part of a recall event; the main page for the event is Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL recalled.
More recalls from Nephron Sterile Compounding Center
All 73| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sodium Chloride Injection 9%, USP, Single-Dose IV recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Phenylephrine HCl Injection, USP, 0.8 mg recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Phenylephrine HCl Injection, USP, 0.4 mg recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |