Why it was recalled
Lack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injection, USP 1 gm vials, lot DB2208, due to a customer complaint for broken/cracked vials which was confirmed through review of retained samples.
Product description
Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, single-use vial, Manufactured in Austria by Sandoz GmbH for Sandoz, Inc. Princeton, NJ 08540, NDC 00781-3451-70 (vial), NDC 00781-3451-96 (box)
Lot numbers, UPCs & expiration codes
Lot #: DB2208, Exp 01/16
Where it was sold
Nationwide 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-597-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 30, 2013
- FDA report date
- Jun 19, 2013
- Quantity
- 297,200 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Incorporated
Original FDA data
Every field from FDA enforcement report D-597-2013, exactly as published.
Show all FDA fields
- City
- Broomfield
- State
- CO
- Status
- Terminated
- Country
- United States
- Event ID
- 65318
- Address
- 2555 W Midway Blvd
- Code information
- Lot #: DB2208, Exp 01/16
- Postal code
- 80020-1632
- Report date
- Jun 19, 2013
- Product type
- Drugs
- Recall number
- D-597-2013
- Classification
- Class II
- Recalling firm
- Sandoz Incorporated
- Product quantity
- 297,200 vials
- Termination date
- Jul 7, 2014
- Reason for recall
- Lack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injection, USP 1 gm vials, lot DB2208, due to a customer complaint for broken/cracked vials which was confirmed through review of retained samples.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, single-use vial, Manufactured in Austria by Sandoz GmbH for Sandoz, Inc. Princeton, NJ 08540, NDC 00781-3451-70 (vial), NDC 00781-3451-96 (box)
- Distribution pattern
- Nationwide and Puerto Rico.
- Recall initiation date
- May 30, 2013
- Initial firm notification
- Letter
- Center classification date
- Jun 11, 2013