Why it was recalled
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Product description
Vancomycin Hydrochloride for Injection, USP, 1 g Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-6533-01.
Lot numbers, UPCs & expiration codes
Lot #: 35-315-DD; Exp 1NOV2015
Where it was sold
Distribution limited to one shipment to The Harvard Drug Group, Livonia, MI for the lots of Vancomycin 500 mg, Ketorolac tromethamine 60 mg/2 mL (30 mg/mL), and Propofol 1% 200 mg/20 mL (10 mg/mL), these lots remained within the control of the distributor and were not further distributed. Distribution was Nationwide for the Vancomycin 1 g product.
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-0390-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 6, 2014
- FDA report date
- Feb 25, 2015
- Quantity
- 90,600 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-0390-2015, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 69573
- Address
- 275 N Field Dr
- Code information
- Lot #: 35-315-DD; Exp 1NOV2015
- Postal code
- 60045-2579
- Report date
- Feb 25, 2015
- Product type
- Drugs
- Recall number
- D-0390-2015
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 90,600 vials
- Termination date
- Dec 15, 2016
- Reason for recall
- Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Vancomycin Hydrochloride for Injection, USP, 1 g Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-6533-01.
- Distribution pattern
- Distribution limited to one shipment to The Harvard Drug Group, Livonia, MI for the lots of Vancomycin 500 mg, Ketorolac tromethamine 60 mg/2 mL (30 mg/mL), and Propofol 1% 200 mg/20 mL (10 mg/mL), these lots remained within the control of the distributor and were not further distributed. Distribution was Nationwide for the Vancomycin 1 g product.
- Recall initiation date
- Oct 6, 2014
- Initial firm notification
- Telephone
- Center classification date
- Feb 13, 2015