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 results were reported to customers as passing. Hence the sterility of these products cannot be assured.
Product description
Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose vial, IV Administration, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126
Lot numbers, UPCs & expiration codes
Lot 06072013@49, Exp 9/5/13
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-1038-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 26, 2013
- FDA report date
- Sep 25, 2013
- Quantity
- 56 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Leiter's Pharmacy
Original FDA data
Every field from FDA enforcement report D-1038-2013, 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 06072013@49, Exp 9/5/13
- Postal code
- 95126-2033
- Report date
- Sep 25, 2013
- Product type
- Drugs
- Recall number
- D-1038-2013
- Classification
- Class II
- Recalling firm
- Leiter's Pharmacy
- Product quantity
- 56 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 results were reported to customers as passing. Hence the sterility of these products cannot be assured.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose vial, IV Administration, 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