CLASS II Drug recall · Reported 25 Sep 2013 · FDA Enforcement Report
Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials Single recalled
Leiter's Pharmacy is recalling Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials Single Use Vial, Compounded by, distributed nationwide in the US. The recall was initiated on 26 Aug 2013 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-1041-2013
- FDA event ID
- 66103
- Recalling firm
- Leiter's Pharmacy, San Jose, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Aug 2013
- FDA classified
- 13 Sep 2013
- Reported
- 25 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 26 Aug 2013 | Recall initiated by company | |
| 13 Sep 2013 | Classified by FDA | +18 days |
| 25 Sep 2013 | Published in enforcement report | +12 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 Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of these products cannot be assured.
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/Phenylephrine PF 1%/1.5% Injectible vials, 1 mL Single Use Vial, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of these products cannot be assured.
Which lots are affected?
Lot # : 07302013@6 Exp 10/28/13
Where was it sold?
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 21 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 66103| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Dextrose 50% Preservative Free SDV Injection Solution recalled | Leiter's Pharmacy | Sterility | Nationwide | |
| CLASS II | Hyaluron (hyaluronidase)/mL Preserved Solution recalled | Leiter's Pharmacy | Sterility | Nationwide | |
| CLASS II | Bevacizumab (Avastin) 2.5mg/ PF Inj recalled by Leiter's Pharmacy | Leiter's Pharmacy | Sterility | Nationwide |
More recalls from Leiter's Pharmacy
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bevacizumab (Avastin) 2.5mg/ PF Inj recalled by Leiter's Pharmacy | Leiter's Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Hyaluron (hyaluronidase)/mL Preserved Solution recalled | Leiter's Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Dextrose 50% Preservative Free SDV Injection Solution recalled | Leiter's Pharmacy | Sterility | Nationwide |