CLASS III Drug recall · Reported 7 Jun 2023 · FDA Enforcement Report
Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride recalled
New England Life Care is recalling Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride, distributed nationwide in the US. The recall was initiated on 22 May 2023 and the FDA has classified it as Class III.
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-0778-2023
- FDA event ID
- 92374
- Recalling firm
- New England Life Care, Woburn, MA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 22 May 2023
- FDA classified
- 1 Jun 2023
- Reported
- 7 Jun 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Drug class
- Cold & Cough Medicine
Timeline
| 22 May 2023 | Recall initiated by company | |
| 1 Jun 2023 | Classified by FDA | +10 days |
| 7 Jun 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Product as listed by the FDA
Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, Massachusetts 01801-1042 United States, NDC 71546-451-25
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Which lots are affected?
Lot # 20230323-728BF8, exp. 08/20/2023
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 New England Life Care
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride IV Bag recalled | New England Life Care | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | SUCCINYLcholine Chloride 200 mg/ (20 mg/mL) BD Syringe recalled | New England Life Care | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | ROcuronium Bromide 50 mg/ ( 10 mg/mL) Syringe recalled | New England Life Care | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Vancomycin HCl added to 0.9% Sodium Chloride IV Bag recalled | New England Life Care | Manufacturing (CGMP) Deviations | Nationwide |
Other Phenylephrine Added To Chloride recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | PHENYLephrine added to 0.9% sodium chloride, 40 mg/* (160 mcg/mL) recalled | Central Admixture Pharmacy Services | Particulate Matter | Nationwide |
| Drug | CLASS II | PHENYLephrine added to 0.9% sodium chloride, 20mg/ (80 mcg/mL), IV recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | PHENYLephrine added to 0.9% sodium chloride 50 mg/ (200mcg/mL), IV recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | phenylephrine 50 mg added to 0.9% sodium chloride recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | PHENYLephrine added to 0.9% sodium chloride, 20 mg/* (80 mcg/mL) recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |