Sun Pharmaceutical Recalls Pantoprazole Sodium Injection Due to Impurity Failures
Sun Pharmaceutical Industries is recalling 20,475 vials of Pantoprazole Sodium for Injection because the product failed impurity and degradation specifications.
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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling 20,475 vials of Pantoprazole Sodium for Injection 40mg/vial. The product is intended for intravenous infusion only and is distributed nationwide. The recall is being conducted because the product failed impurity and degradation specifications.
The affected product is identified by NDC 62756-129-40 and includes lot numbers JKU3595A, JKU3596A, JKU3597A, and JKU3629A, all with an expiration date of 02/2021. The medication was manufactured by Sun Pharmaceutical Industries Ltd. in India and distributed by Sun Pharmaceutical Industries, Inc. in Cranbury, New Jersey.
Healthcare providers and patients should stop using the affected vials and contact their pharmacist or Sun Pharmaceutical Industries for further instructions. This recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM)
- Brand
- PANTOPRAZOLE SODIUM
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Prescription Injection
- Hazard
- Affected units
- 20,475
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 (5)
- JKU3595A
- JKU3596A
- JKU3597A
- and JKU3629A
- Exp 02/2021
UPCs (1)
- 0362756129405
Distribution
Distributed nationwide across the United States.
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