Why it was 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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot # : 07302013@6 Exp 10/28/13
Where it was sold
Nationwide
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-1041-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 26, 2013
- FDA report date
- Sep 25, 2013
- Quantity
- 728 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Leiter's Pharmacy
Original FDA data
Every field from FDA enforcement report D-1041-2013, exactly as published.
Show all FDA fields
- City
- San Jose
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 66103
- Address
- 1700 Park Ave
- Code information
- Lot # : 07302013@6 Exp 10/28/13
- Postal code
- 95126-2033
- Report date
- Sep 25, 2013
- Product type
- Drugs
- Recall number
- D-1041-2013
- Classification
- Class II
- Recalling firm
- Leiter's Pharmacy
- Product quantity
- 728 vials
- Termination date
- Aug 14, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- 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 13, 2013