Why it was recalled
Presence of Particulate Matter: glass particulate found in vial
Product description
Vancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only. Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-6531-02
Lot numbers, UPCs & expiration codes
Lot: 632153A; Exp. 03/18
Where it was sold
Nationwide USA and Puerto Rico
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-0123-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 30, 2017
- FDA report date
- Dec 27, 2017
- Quantity
- 102,500 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0123-2018, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 78000
- Address
- 235 E 42nd St
- Code information
- Lot: 632153A; Exp. 03/18
- Postal code
- 10017-5703
- Report date
- Dec 27, 2017
- Product type
- Drugs
- Recall number
- D-0123-2018
- Classification
- Class I
- Recalling firm
- Pfizer Inc.
- Product quantity
- 102,500 vials
- Termination date
- Nov 8, 2018
- Reason for recall
- Presence of Particulate Matter: glass particulate found in vial
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Vancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only. Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-6531-02
- Distribution pattern
- Nationwide USA and Puerto Rico
- Recall initiation date
- Aug 30, 2017
- Initial firm notification
- Press Release
- Center classification date
- Dec 20, 2017