Sandoz Recalls Cefazolin Injection Vials Due to Sterility Concerns
Sandoz Inc. is recalling Cefazolin for Injection, USP 1 gm vials, lot DB2208, due to a lack of assurance of sterility caused by broken or cracked vials.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility in a parenteral drug, which poses a significant risk of serious health consequences such as infection.
Plain-English summary
Sandoz Inc. is recalling Cefazolin for Injection, USP 1 gm vials, lot DB2208, due to a lack of assurance of sterility. The recall was initiated after a customer complaint regarding broken or cracked vials, which was confirmed through the review of retained samples.
The affected product is Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, single-use vial. The product was manufactured in Austria by Sandoz GmbH for Sandoz, Inc. in Princeton, NJ. The specific lot number is DB2208 with an expiration date of 01/16. The NDC numbers are 00781-3451-70 for the vial and 00781-3451-96 for the box.
A total of 297,200 vials were distributed nationwide and in Puerto Rico. The FDA has classified this recall as Class II. Consumers and healthcare providers should stop using the affected product and contact Sandoz Incorporated for further instructions.
The recalled product
- Product
- 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)
- Manufacturer
- Sandoz Incorporated
- Category
- Drug — Antibiotic Injection
- Hazard
- Affected units
- 297,200
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: DB2208
- Exp 01/16
Distribution
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