CLASS II Drug recall · Reported 5 Jan 2022 · FDA Enforcement Report
Fentanyl Citrate, in 0.9% Sodium Chloride Injection recalled by SterRx
SterRx is recalling Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per, (10 mcg per mL), distributed nationwide in the US. The recall was initiated on 12 Nov 2021 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-0316-2022
- FDA event ID
- 89059
- Recalling firm
- SterRx, Plattsburgh, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Nov 2021
- FDA classified
- 29 Dec 2021
- Reported
- 5 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 12 Nov 2021 | Recall initiated by company | |
| 29 Dec 2021 | Classified by FDA | +47 days |
| 5 Jan 2022 | Published in enforcement report | +7 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, 1 mg per 100 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-01.
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
S21349/CAI 23-Mar-22 S21356/CAP 1-Apr-22 S21361/CAU 2-Apr-22
Where was it sold?
U.S.A. Nationwide
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
25 other products · FDA event 89059This product is part of a recall event; the main page for the event is Morphine Sulfate, in 0.9% Sodium Chloride Injection recalled by SterRx.
More recalls from SterRx
All 35| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Norepinephrine 32 mg per (128 mcg per mL) recalled by SterRx | SterRx | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine 8 mg per (32 mcg per mL) recalled by SterRx | SterRx | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine 16 mg per (64 mcg per mL) recalled by SterRx | SterRx | Sterility | Nationwide |
| Drug | CLASS II | Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq recalled by SterRx | SterRx | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine 4 mg per (16 mcg per mL) recalled by SterRx | SterRx | 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 |