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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 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
- Manufacturer
- AuroMedics Pharma LLC
- Category
- Drug — Antibiotic Injection
- 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.
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