CLASS II Drug recall · Reported 16 Aug 2017 · FDA Enforcement Report
Phenylephrine HCL in 0.9% Sodium Chloride, 1 mg recalled
Cantrell Drug is recalling Phenylephrine HCL in 0.9% Sodium Chloride, 1 mg/ (100 mcg/mL) Single-Dose Syringe, distributed nationwide in the US. The recall was initiated on 14 Jul 2017 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-1074-2017
- FDA event ID
- 77780
- Recalling firm
- Cantrell Drug, Little Rock, AR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Jul 2017
- FDA classified
- 9 Aug 2017
- Reported
- 16 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Cold & Cough Medicine
Timeline
| 14 Jul 2017 | Recall initiated by company | |
| 9 Aug 2017 | Classified by FDA | +26 days |
| 16 Aug 2017 | 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 Sterility Assurance.
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
Phenylephrine HCL in 0.9% Sodium Chloride 10 mL, 1 mg/10 mL (100 mcg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-171-12
Where it was distributed
Nationwide within the US
Questions about this recall
Why was it recalled?
Lack of Sterility Assurance.
Which lots are affected?
Lot #: 9556, BUD: 7/26/2017; 9566, BUD: 7/30/2017; 9584, BUD; 8/1/2017; 9613, BUD: 8/6/2017; 9656, BUD: 8/14/2017; 9798, BUD: 9/11/2017; 9812, BUD: 8/31/2017; 9819, BUD: 9/16/2017; 9836, BUD: 9/17/2017; 9944, BUD: 10/3/2017; 10158, 10493, 10565, BUD: 10/30/2017
Where was it sold?
Nationwide within the US
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
17 other products · FDA event 77780More recalls from Cantrell Drug
All 52| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ephedrine Sulfate in 0.9% Sodium Chloride, 50 mg recalled | Cantrell Drug | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine Bitartrate 4 mg Added to 0.9% Sodium recalled | Cantrell Drug | Sterility | Nationwide |
| Drug | CLASS II | Diltiazem HCl 125 mg in 5% Dextrose Single-Dose recalled | Cantrell Drug | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine Bitartrate 8 mg Added to 0.9% Sodium recalled | Cantrell Drug | Sterility | Nationwide |
| Drug | CLASS II | Adenosine in 0.9% Sodium Chloride, 90 mg recalled by Cantrell Drug | Cantrell Drug | Sterility | Nationwide |
Other Phenylephrine recalls
All 83| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phenylephrine Hydrochloride Injectable Solution, 40mg recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg recalled | Denver Solutions | Sterility | Nationwide |
| Drug | CLASS I | Phenylephrine HCl Injection, USP 100 mg/ (10 mg/mL) vials recalled | Provepharm | Particulate Matter | Nationwide |
| Drug | CLASS II | phenylephrine in 0.9% Sodium Chloride Inj, 1mg per (100 mcg/mL) recalled | Hikma Injectables USA | Sterility | Nationwide |
| Drug | CLASS I | Phenylephrine in 0.9% Sodium Chloride Injection recalled | Hikma Injectables USA | Labeling Errors | 5 states |