Why it was 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.
Product description
Lidocaine 1% PF Sterile Injection, 30 mL Single Dose Vial, Pharmacy Creations, Randolph, NJ.
Lot numbers, UPCs & expiration codes
Lot # 214490.00, Exp 11/29/2013
Where it was sold
NJ
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1028-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 26, 2013
- FDA report date
- Sep 18, 2013
- Quantity
- 50 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmacy Creations
Original FDA data
Every field from FDA enforcement report D-1028-2013, exactly as published.
Show all FDA fields
- City
- Randolph
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 66100
- Address
- 540 Route Ten West
- Code information
- Lot # 214490.00, Exp 11/29/2013
- Postal code
- 07869
- Report date
- Sep 18, 2013
- Product type
- Drugs
- Recall number
- D-1028-2013
- Classification
- Class II
- Recalling firm
- Pharmacy Creations
- Product quantity
- 50 vials
- Termination date
- Apr 25, 2016
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lidocaine 1% PF Sterile Injection, 30 mL Single Dose Vial, Pharmacy Creations, Randolph, NJ.
- Distribution pattern
- NJ
- Recall initiation date
- Aug 26, 2013
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Sep 12, 2013