CLASS II Drug recall · Reported 18 Sep 2013 · FDA Enforcement Report
Lidocaine 1% PF Sterile Injection Single Dose Vial recalled
Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection Single Dose Vial, Pharmacy Creations, Randolph, NJ, distributed in New Jersey. 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-1028-2013
- FDA event ID
- 66100
- Recalling firm
- Pharmacy Creations, Randolph, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Aug 2013
- FDA classified
- 12 Sep 2013
- Reported
- 18 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 | |
| 12 Sep 2013 | Classified by FDA | +17 days |
| 18 Sep 2013 | Published in enforcement report | +6 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: Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection and EDTA disodium 150 mg/mL due to lack of assurance of 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 1% PF Sterile Injection, 30 mL Single Dose Vial, Pharmacy Creations, Randolph, NJ.
Where it was distributed
NJ
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection and EDTA disodium 150 mg/mL due to lack of assurance of sterility.
Which lots are affected?
Lot # 214490.00, Exp 11/29/2013
Where was it sold?
NJ
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
1 other product · FDA event 66100| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | EDTA disodium 150 mg/mL Sterile Injection Multi Dose Vial recalled | Pharmacy Creations | Sterility | NJ |
More recalls from Pharmacy Creations
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Magnesium Chloride 20% (200mg/mL) Sterile Injection Multi-Dose Vial recalled | Pharmacy Creations | Sterility | 4 states |
| Drug | CLASS I | Tropi/Cyclo/Phenyl/Tobra/Flurb recalled by Pharmacy Creations | Pharmacy Creations | Sterility | 4 states |
| Drug | CLASS I | Glutathione 100mg/mL Sterile Injection Multi Dose Vial recalled | Pharmacy Creations | Sterility | 4 states |
| Drug | CLASS I | Ascorbic Acid 500 mg/mL Sterile Injection Multi-dose Vial recalled | Pharmacy Creations | Sterility | 4 states |
| Drug | CLASS I | Ascorbic Acid 500 mg/mL Sterile Injection Multi-dose Vial recalled | Pharmacy Creations | Mold | NJ, NY, PR |