AuroMedics Recalls Piperacillin and Tazobactam Injection Due to Glass Particulates
AuroMedics Pharma LLC is recalling 77,400 vials of Piperacillin and Tazobactam for Injection due to confirmed visible glass 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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA classified this recall as Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
AuroMedics Pharma LLC is recalling 77,400 vials of Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial. The recall was initiated after a confirmed customer report identified visible particulate matter in the product, which was confirmed to be glass.
The affected product is distributed nationwide in the USA. The specific lots involved are PP0317061-A and PP0317049-A, with an expiration date of August 2019. The product is a prescription-only medication intended for intravenous use only.
Healthcare providers and patients should stop using the affected lots immediately. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
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
- 77,400
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 #s: PP0317061-A
- PP0317049-A
- EXP August 2019
UPCs (3)
- 0355150119301
- 0355150120307
- 0355150121502
Distribution
Distributed nationwide across the United States.
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