Teva Recalls Amikacin Sulfate Injection Due to Glass Particulate Matter
Teva Pharmaceuticals USA is recalling Amikacin Sulfate injection vials because glass particulate matter was identified in one vial.
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 agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Teva Pharmaceuticals USA is recalling 6,291 units of Amikacin Sulfate injection USP, 1 gm/4 mL (250 mg/mL) 4mL vials. The recall was initiated because particulate matter, identified as glass, was found in one vial.
The affected product is Lot #4750915, with an expiration date of 9/2017. The product was distributed nationwide and in Puerto Rico. The NDC numbers for the individual pack and shelf pack are 0703-9040-01 and 0703-9040-03, respectively.
Healthcare providers and patients should stop using the affected vials and contact Teva Pharmaceuticals USA for further instructions or replacement.
The recalled product
- Product
- Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manufactured in Hungary For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454. Individual Pack NDC 0703-9040-01, Shelf Pack NDC 0703-9040-03
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Injectable
- Affected units
- 6,291
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 #: 4750915
- Exp 9/2017
Distribution
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