CLASS II Drug recall · Reported 31 Oct 2018 · FDA Enforcement Report
Lidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL per glass vial recalled
RXQ Compounding is recalling Lidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL per glass vial, distributed nationwide in the US. The recall was initiated on 25 Sep 2018 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-0130-2019
- FDA event ID
- 81316
- Recalling firm
- RXQ Compounding, Athens, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Sep 2018
- FDA classified
- 1 Nov 2018
- Reported
- 31 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 25 Sep 2018 | Recall initiated by company | |
| 31 Oct 2018 | Published in enforcement report | +36 days |
| 1 Nov 2018 | Classified by FDA | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent drug: During testing of the retention sample, the firm discovered that the product was sub-potent.
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
Lidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL, 50 mL per glass vial, Rx only, 340 West State Street, Unit 9, Athens, OH 45701. NDC 7073197450
Where it was distributed
U.S.A. nationwide
Questions about this recall
Why was it recalled?
Subpotent drug: During testing of the retention sample, the firm discovered that the product was sub-potent.
Which lots are affected?
Lot# 04042018:58, Exp 10/17/18
Where was it sold?
U.S.A. nationwide
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 RXQ Compounding
All 88| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Edetate Calcium Disodium 150MG/ML Injectable per vial recalled | RXQ Compounding | Sterility | Nationwide |
| Drug | CLASS II | Neostigmine Methyl Sulfate 1MG/ML Inj Sol Syr per syringe recalled | RXQ Compounding | Sterility | Nationwide |
| Drug | CLASS II | Ondansetron 2 MG/ML Injection Solution (Npf) per vial recalled | RXQ Compounding | Sterility | Nationwide |
| Drug | CLASS II | Glutathione 200MG/ML (Pfv) Injection Soln per vial recalled | RXQ Compounding | Sterility | Nationwide |
| Drug | CLASS II | Phenylephrine HCL 100 Mcg/ML IN Nacl 0.9% Syr per syringe recalled | RXQ Compounding | Sterility | Nationwide |