Agency classClass IIOur severity:Severe FDA (Drugs)·D-0024-2017·Announced 2016-10-19

Teva Recalls Amikacin Sulfate Injection Due to Manufacturing Deviations

Teva Pharmaceuticals USA is voluntarily recalling 11,844 vials of Amikacin Sulfate Injection due to Current Good Manufacturing Practice (CGMP) deviations.

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. According to the rubric, FDA Class II recalls with potential for significant injury or property damage, or those involving structural defects or high-risk pathogens, are rated as Severe (4). While no specific injuries are reported, the classification and nature of the drug product warrant a Severe rating.

Plain-English summary

Teva Pharmaceuticals USA is voluntarily recalling 11,844 vials of Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL). The affected product is identified by NDC 0703-9040-01 (individual pack) and NDC 0703-9040-03 (shelf-pack carton of 10 vials). The recall was initiated on July 29, 2016, and was classified as Class II by the FDA.

The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations. The affected lots are # 2381114, 2771114, and 4760915. The product was distributed nationwide and in Puerto Rico. The recall status is currently Terminated, with a termination date of February 5, 2018.

Healthcare providers and patients should check their inventory and records for the specific lot numbers listed above. If the product is found, it should be returned to the supplier or the recalling firm. No specific adverse health consequences are reported in the source text, but the recall is precautionary due to manufacturing quality issues.

The recalled product

Product: Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9040-01 (individual pack), NDC 0703-9040-03 (shelf-pack carton of 10 vials).
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Antibiotic Injection
Hazard: cgmp-deviations
manufacturing-defect
Affected units: 11,844

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 (3)

Lot # 2381114
2771114
4760915

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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Same hazard · cgmp deviations