Why it was recalled
Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product.
Product description
Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous Use, packaged in 100 mL glass vial, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6510-01
Lot numbers, UPCs & expiration codes
Lot # 591053A, Exp 11/1/2017
Where it was sold
U.S. 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-0638-2017
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jan 24, 2017
- FDA report date
- Apr 12, 2017
- Quantity
- 30,880 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc., A Pfizer Company
Original FDA data
Every field from FDA enforcement report D-0638-2017, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 76284
- Address
- 275 N Field Dr
- Code information
- Lot # 591053A, Exp 11/1/2017
- Postal code
- 60045-2579
- Report date
- Apr 12, 2017
- Product type
- Drugs
- Recall number
- D-0638-2017
- Classification
- Class I
- Recalling firm
- Hospira Inc., A Pfizer Company
- Product quantity
- 30,880 vials
- Termination date
- Apr 26, 2018
- Reason for recall
- Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous Use, packaged in 100 mL glass vial, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6510-01
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Jan 24, 2017
- Initial firm notification
- Letter
- Center classification date
- Apr 5, 2017