Class II · Moderate risk
Phenylephrine Hydrochloride Injectable Solution
cGMP deviations.
Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Cause type: Other
Recalls whose stated reason does not fall into the categories above. See the recall's own reason text for the specifics. All other recalls.
What was recalled
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
Affected NDC
71546-0451-25
Compare with the code on your package — it is the most precise check available.
Drug: Phenylephrine
- Recalling firm
- New England Life Care, Inc. dba Advanced Compounding Solutions
- NDC code
- 71546-451-25
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0778-2023 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Phenylephrine recalls
See all
Class II · Moderate risk
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac…
Incorrect Product Formulation
Class II · Moderate risk
Phenylephrine HCI
CGMP Deviations
Class III · Low risk
Tropicamide-Proparacaine-Phenylephrine-Ketorolac
Sub-Potent Drug: Subpotent assay results during stability testing.
Class II · Moderate risk
PHENYLephrine HCl in 0.9% Sodium Chloride
Lack of Assurance of Sterility: Leaking/damaged syringes.
Other recalls by New England Life Care, Inc. dba Advanced Compounding Solutions
All 2023 recalls
Class II · Moderate risk
Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Class II · Moderate risk
ROcuronium Bromide 50 mg/5 mL
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Class II · Moderate risk
PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Class II · Moderate risk
SUCCINYLcholine Chloride 200 mg/10mL
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.