CLASS II Drug recall · Reported 9 Jan 2019 · FDA Enforcement Report
Lidocaine/Epinepherine liquid 1%/ 1:1000, RX recalled
Hiers Enterprises is recalling Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include injectable, distributed in Oregon. 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-0398-2019
- FDA event ID
- 81883
- Recalling firm
- Hiers Enterprises, Roseburg, OR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Jan 2019
- FDA classified
- 27 Jan 2019
- Reported
- 9 Jan 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 2 Jan 2019 | Recall initiated by company | |
| 9 Jan 2019 | Published in enforcement report | +7 days |
| 27 Jan 2019 | Classified by FDA | +18 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of sterility assurance.
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/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include injectable medications, sterile solutions, eye drops, and eye ointments
Where it was distributed
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.
Questions about this recall
Why was it recalled?
Lack of sterility assurance.
Which lots are affected?
08072018@30
Where was it sold?
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.
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
16 other products · FDA event 81883This product is part of a recall event; the main page for the event is Methocarbamol liquid 100mg/ml, RX, glass vial recalled.
More recalls from Hiers Enterprises
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cyclosporin liquid 0.5%, Rx recalled by Hiers Enterprises | Hiers Enterprises | Sterility | OR |
| Drug | CLASS II | Cyclosporin liquid 1%, Rx recalled by Hiers Enterprises | Hiers Enterprises | Sterility | OR |
| Drug | CLASS II | Epinephrine liquid 1:1000, RX, glass vial recalled by Hiers Enterprises | Hiers Enterprises | Sterility | OR |
| Drug | CLASS II | Glutathione liquid, 100mg/ml recalled by Hiers Enterprises | Hiers Enterprises | Sterility | OR |
| Drug | CLASS II | Vitamin B12 liquid 1000mcg/ml, RX, glass vial recalled | Hiers Enterprises | Sterility | OR |
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 |