Why it was recalled
Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Product description
Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0924-59
Lot numbers, UPCs & expiration codes
Lot: 20161212@44, Exp 2/10/2017; Lot: 20161230@40, Exp 2/28/2017
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-0642-2017
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Feb 3, 2017
- FDA report date
- Apr 12, 2017
- Quantity
- 490 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SCA Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0642-2017, exactly as published.
Show all FDA fields
- City
- Little Rock
- State
- AR
- Status
- Terminated
- Country
- United States
- Event ID
- 76395
- Address
- 8821 Knoedl Ct
- Code information
- Lot: 20161212@44, Exp 2/10/2017; Lot: 20161230@40, Exp 2/28/2017
- Postal code
- 72205-4600
- Report date
- Apr 12, 2017
- Product type
- Drugs
- Recall number
- D-0642-2017
- Classification
- Class I
- Recalling firm
- SCA Pharmaceuticals
- Product quantity
- 490 bags
- Termination date
- Oct 19, 2017
- Reason for recall
- Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0924-59
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Feb 3, 2017
- Initial firm notification
- Letter
- Center classification date
- Apr 5, 2017