CLASS I Drug recall · Reported 26 Nov 2014 · FDA Enforcement Report
Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine recalled
Abrams Royal Pharmacy is recalling Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine 0.0022 mg/mL/Hyaluronidase13.64, distributed in Texas. The recall was initiated on 19 Apr 2013 and the FDA has classified it as Class I.
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-0251-2015
- FDA event ID
- 68342
- Recalling firm
- Abrams Royal Pharmacy, Dallas, TX
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 19 Apr 2013
- FDA classified
- 17 Nov 2014
- Reported
- 26 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 19 Apr 2013 | Recall initiated by company | |
| 17 Nov 2014 | Classified by FDA | +577 days |
| 26 Nov 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine 0.0022 mg/mL/Hyaluronidase13.64 u/mL, supplied in 11 mL Sterile Syringes, Rx only, Compounded med, Single use only, (Red Block) ABRAMS ROYAL Compounding Pharmacy, Dallas, TX
Where it was distributed
Texas
Questions about this recall
Why was it recalled?
Non-Sterility
Which lots are affected?
Lot# 041013-13 (also been written as "041013@13") Exp: 06/09/2013
Where was it sold?
Texas
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 Abrams Royal Pharmacy
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Calcium Chloride Preservative Free Sterile injection, 100 mg/ml vial recalled | Abrams Royal Pharmacy | Sterility | TX |
| Drug | CLASS I | Trace Mineral-5 MDV, supplied in vials, Each ML contains recalled | Abrams Royal Pharmacy | Other Bacterial Contamination | Nationwide |
Other Lidocaine recalls
All 119| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS III | Lidolog Kit, Kit Contains: Lidocaine HCl Injection recalledLidolog Kit | Asclemed USA | Other | TN |
| Drug | CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Lidocaine HCl Injection USP, 1% (10 mg/mL) single dose ampule recalledLidocaine Hydrochloride | Asclemed USA | Sterility | Nationwide |