CLASS II Drug recall · Reported 26 Jul 2023 · FDA Enforcement Report
Vancomycin HCl added to 0.9% Sodium Chloride IV Bag recalled
New England Life Care is recalling Vancomycin HCl added to 0.9% Sodium Chloride IV Bag (515 total volume), distributed nationwide in the US. The recall was initiated on 10 Jul 2023 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-0929-2023
- FDA event ID
- 92690
- Recalling firm
- New England Life Care, Woburn, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jul 2023
- FDA classified
- 19 Jul 2023
- Reported
- 26 Jul 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Antibiotics
Timeline
| 10 Jul 2023 | Recall initiated by company | |
| 19 Jul 2023 | Classified by FDA | +9 days |
| 26 Jul 2023 | 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
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Product as listed by the FDA
Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 total volume), Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC 71546-310-50;
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Which lots are affected?
Lot # 20230524-0113AB, Exp 22AUG2023
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 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
3 other products · FDA event 92690| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | ROcuronium Bromide 50 mg/ ( 10 mg/mL) Syringe recalled | New England Life Care | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | SUCCINYLcholine Chloride 200 mg/ (20 mg/mL) BD Syringe recalled | New England Life Care | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride IV Bag recalled | New England Life Care | Manufacturing (CGMP) Deviations | Nationwide |
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 III | Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride recalled | New England Life Care | Other | Nationwide |