Agency classClass IIOur severity:Severe FDA (Drugs)·D-0023-2017·Announced 2016-10-19

Teva Recalls Amikacin Sulfate Injection Due to Manufacturing Deviations

Teva Pharmaceuticals USA is voluntarily recalling 27,547 vials of Amikacin Sulfate Injection due to CGMP deviations. The recall covers lots distributed nationwide and in Puerto Rico.

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 source text explicitly states the agency classification is 'Class II'. According to the severity rubric, an FDA Class II recall must be scored as 4 (Severe), regardless of whether specific injuries are reported in the text.

Plain-English summary

Teva Pharmaceuticals USA is voluntarily recalling 27,547 vials of Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL). The affected product is identified by NDC 0703-9032-01 (individual pack) and NDC 0703-9032-03 (shelf-pack carton of 10 vials). The recall was initiated on July 29, 2016, and was terminated on February 5, 2018.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The affected lots are # 7080315, 7400315, 7410315, and 7980415. The product was distributed nationwide and in Puerto Rico.

The FDA classified this recall as Class II, which means the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Consumers and healthcare providers should check their inventory for the specific lot numbers listed and stop using the product if it matches the recalled lots.

The recalled product

Product: Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-03 (shelf-pack carton of 10 vials).
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Injectable Antibiotic
Hazard: cgmp-deviation
quality-control
Affected units: 27,547

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 (4)

Lot # 7080315
7400315
7410315
7980415

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 2 recalled by Teva Pharmaceuticals USA 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 2 products in this recall →

Same manufacturer · Teva Pharmaceuticals USA

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