The Recall Desk
SevereFDA (Drugs)·D-1495-2016·Announced 2016-09-14

Teva Recalls Linezolid Injection Due to Manufacturing Deviations

Teva North America is voluntarily recalling 92,480 containers of Linezolid Injection 600 mg/300 mL due to CGMP deviations. The recall covers products distributed nationwide and in Puerto Rico.

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. According to the rubric, FDA Class II recalls with potential for serious adverse health consequences or temporary/reversible injury are rated as Severe (4).

Plain-English summary

Teva North America has initiated a voluntary recall of Linezolid Injection 600 mg/300 mL, a prescription-only medication manufactured in Hungary. The recall affects 92,480 containers, including single-use containers (NDC 0703-9060-31) and boxes of 10 single-use containers (NDC 0703-9060-33). The recall was initiated on June 17, 2016, and was classified as Class II by the FDA.

The reason for the recall is cited as Current Good Manufacturing Practice (CGMP) deviations. The affected lots are all within their expiration dates. The products were distributed nationwide and in Puerto Rico. The recall was initiated by the firm and was later terminated on February 7, 2017.

Healthcare providers and patients should check their inventory for the specific NDC numbers listed above. If you have this product, you should stop using it and contact your healthcare provider or the manufacturer for instructions on return or disposal. This recall is voluntary and was initiated by Teva North America.

The recalled product

Product
Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-9060-31- (Single Use Container), NDC# 0703-9060-33 (Box of 10 Singe Use Containers)
Manufacturer
Teva North America
Category
Drug — Antibiotic Injection
Hazard
Affected units
92,480

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 (1)

  • All Lots Within Expiry

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 4 recalled by Teva North America under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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