Aurobindo Recalls Discolored Pantoprazole Sodium Injection Vials
Aurobindo Pharma USA Inc is recalling 29,800 vials of Pantoprazole Sodium for Injection due to discoloration. The affected vials contain powder with a yellowish-brownish appearance.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a cosmetic defect (discoloration) with no reported injuries or illnesses.
Plain-English summary
Aurobindo Pharma USA Inc is voluntarily recalling 29,800 vials of Pantoprazole Sodium for Injection, 40mg per vial. The recall was initiated because some vials were found to contain powder with a yellowish-brownish appearance, indicating discoloration.
The affected product is identified by Lot # CPO160028 and has an expiration date of June 2018. The product was distributed nationwide in the US. The medication is a prescription-only intravenous drug manufactured in India for Auromedics Pharma LLC.
Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If the product is found, it should be removed from use and returned to the supplier or disposed of according to local regulations. No specific instructions for patient management are provided in the source text.
The recalled product
- Product
- PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM)
- Brand
- PANTOPRAZOLE SODIUM
- Manufacturer
- Aurobindo Pharma USA Inc
- Category
- Drug — Injection
- Hazard
- Affected units
- 29,800
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 #: CPO160028
- Exp. June 2018
Distribution
Distributed nationwide across the United States.
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