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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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…
- Manufacturer
- Teva North America
- Category
- Drug — Injectable
- 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.
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