Why it was recalled
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Product description
Vancomycin Hydrochloride for Injection, USP, 500 mg Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4332-01.
Lot numbers, UPCs & expiration codes
One shipment of Lot #: 34-366-8E02; Exp 1OCT2015 to The Harvard Drug Group, Livonia, MI
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-0387-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 6, 2014
- FDA report date
- Feb 25, 2015
- Quantity
- 200 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-0387-2015, 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
- One shipment of Lot #: 34-366-8E02; Exp 1OCT2015 to The Harvard Drug Group, Livonia, MI
- Postal code
- 60045-2579
- Report date
- Feb 25, 2015
- Product type
- Drugs
- Recall number
- D-0387-2015
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 200 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, 500 mg Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4332-01.
- 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