The Recall Desk
SevereFDA (Drugs)·D-0868-2016·Announced 2016-06-01

Teva Recalls Linezolid Injection Bags Due to Sterility Concerns

Teva North America is recalling 546 bags of Linezolid Injection due to potential leaking that compromises sterility.

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 the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection.

Plain-English summary

Teva North America is recalling 546 bags of Linezolid Injection, 600 mg/300 mL Single use container bags. The product is packaged in boxes of 10 bags and is available by prescription only. The specific lot number is 2520715, with an expiration date of 7/17.

The recall was initiated due to a lack of assurance of sterility caused by the potential for the bags to leak. This defect could compromise the safety of the medication for patients.

The affected product was distributed nationwide. Healthcare providers and patients should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or further instructions.

The recalled product

Product
Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged in 10 x 300 mL Single Use Container bags per Box Pack (NDC 0703-9060-33), Rx only, Manufactured In Hungary By: Teva Pharmaceutical Works Ltd., Hungary, H-2100 Godollo, Tancsics M. ut 82 Hung
Manufacturer
Teva North America
Affected units
546

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 # 2520715
  • Exp Date: 7/17

Distribution

Distributed nationwide across the United States.