CLASS I Drug recall · Reported 2 Jan 2019 · FDA Enforcement Report
Phenylephrine HCl, 1 mg in Sterile Water for Injection recalled
Advanced Pharma is recalling Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS Injectable Solution, 1 mg, distributed in New Mexico, Ohio, Texas. The recall was initiated on 29 Nov 2018 and the FDA has classified it as Class I.
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-0347-2019
- FDA event ID
- 81685
- Recalling firm
- Advanced Pharma, Houston, TX
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 29 Nov 2018
- FDA classified
- 7 Jan 2019
- Reported
- 2 Jan 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Labeling Errors
- Drug class
- Cold & Cough Medicine
Timeline
| 29 Nov 2018 | Recall initiated by company | |
| 2 Jan 2019 | Published in enforcement report | +34 days |
| 7 Jan 2019 | Classified by FDA | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".
Product as listed by the FDA
Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (10 mcg per mL), 10 mL syringe, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, (877) 794-0404; NDC: 42852-802-61.
Where it was distributed
Heath care facilities in NM, TX, and OH
Questions about this recall
Why was it recalled?
Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".
Which lots are affected?
Lot: 11/01/18 8847 80261S, BUD: 03/31/19
Where was it sold?
Heath care facilities in NM, TX, and OH
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 Phenylephrine recalls
All 122| 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 |