AuroMedics Recalls Pantoprazole Sodium Injection Due to Glass Particulate
AuroMedics Pharma LLC is recalling 66,100 vials of Pantoprazole Sodium for Injection because one vial contained a piece of glass.
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 recall is classified as FDA Class I, which meets the rubric criteria for a Critical severity score of 5.
Plain-English summary
AuroMedics Pharma LLC is recalling 66,100 vials of Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only. The product is manufactured in India for AuroMedics Pharma LLC and carries NDC 55150-202-00. The specific lot number is CPO170035.
The recall was initiated because one vial from the lot was found to contain a piece of glass. This is a Class I recall, which indicates a reasonable probability that use of the product may cause serious adverse health consequences or death.
The product was distributed nationwide in the USA. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatments or replacements.
The recalled product
- Product
- PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM)
- Brand
- PANTOPRAZOLE SODIUM
- Manufacturer
- AuroMedics Pharma LLC
- Category
- Drug — Injection
- Affected units
- 66,100
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 (1)
- Lot # CPO170035
Distribution
Distributed nationwide across the United States.
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