The Recall Desk
SevereFDA (Drugs)·D-1030-2018·Announced 2018-07-18

AuroMedics Recalls Piperacillin and Tazobactam Injection Vials Due to Particulate Matter

AuroMedics Pharma LLC is recalling 73,620 vials of Piperacillin and Tazobactam for Injection due to the presence of glass and silicone particulate matter.

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 severity score of at least 4 per the rubric. The presence of glass and silicone particulate matter in an intravenous injection presents a significant risk of injury.

Plain-English summary

AuroMedics Pharma LLC is recalling 73,620 single-dose vials of Piperacillin and Tazobactam for Injection USP 3.375 grams per vial. The recall is being conducted because the product was found to contain particulate matter, which has been identified as glass and silicone material.

The affected product is a prescription-only intravenous medication manufactured in India for AuroMedics Pharma LLC. The specific lot numbers involved are PP0317059-A, PP0317012-A (expiration February 2019), and PP0317012-A (expiration August 2019). The product was distributed nationwide in the USA.

Healthcare providers and patients should stop using the affected vials immediately. Consumers should check their medication for the specific NDC numbers 55150-119-30, 55150-120-30, or 55150-121-50 and the lot numbers listed above. If you have questions about this recall, contact AuroMedics Pharma LLC or your healthcare provider.

The recalled product

Product
PIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM)
Brand
PIPERACILLIN AND TAZOBACTAM
Affected units
73,620

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: PP0317059-A
  • Exp February 2019: PP0317012-A
  • Exp: August 2019.

UPCs (3)

  • 0355150119301
  • 0355150120307
  • 0355150121502

Distribution

Distributed nationwide across the United States.

Same brand · PIPERACILLIN AND TAZOBACTAM