CLASS II Drug recall · Reported 16 Jan 2019 · FDA Enforcement Report
0.9% Buffered Lidocaine HCl (buffered recalled by PharMEDium Services
PharMEDium Services is recalling 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) in BD Syringe, 10, distributed nationwide in the US. The recall was initiated on 2 Jan 2019 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-0374-2019
- FDA event ID
- 81895
- Recalling firm
- PharMEDium Services, Cleveland, MS
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Jan 2019
- FDA classified
- 14 Jan 2019
- Reported
- 16 Jan 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 2 Jan 2019 | Recall initiated by company | |
| 14 Jan 2019 | Classified by FDA | +12 days |
| 16 Jan 2019 | Published in enforcement report | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 per carton, b.) 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) 5 mL in 5 mL BD Syringe, 10 per carton Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478.
Where it was distributed
Product was distributed throughout the United States.
Questions about this recall
Why was it recalled?
Subpotent
Which lots are affected?
Service Code 2K2466 and 2K2470 183320004S, 183330008S, 183340002S, 183340003S, 183300004S, 183310007S, 183370041S, 183310043S, 183370042S, 183320003S, 183380007S, 183250013S, 183250014S, 183320005S, 183330009S, 183370007S, 183390044S, 183400006S, 183410003S.
Where was it sold?
Product was distributed throughout the United States.
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.
More recalls from PharMEDium Services
All 291| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | rocuronium Bromide, 10 mg per mL, 50 mg per BD Syringe recalled | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | ePHEDrine Sulfate, 5 mg per mL, 25 mg recalled by PharMEDium Services | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | fentaNYL Citrate 10 mcg per mL, 2,500 mcg per in a LifeCare recalled | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | nICARdipine HCl (0.1 mg/mL) 1 mg recalled by PharMEDium Services | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | rocuronium Bromide 10 mg per mL 50 mg per BD Syringe recalled | PharMEDium Services | Sterility | Nationwide |
Other Buffered Lidocaine (buffered recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | 0.9% Buffered Lidocaine HCl (buffered recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |