Pantoprazole Sodium Oral Suspension Recalled for Discoloration
Sun Pharmaceutical recalls Pantoprazole Sodium oral suspension nationwide due to product discoloration. Lot MHC1317A with approximately 14,064 units was distributed in the USA.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II voluntary recall for product discoloration without reported illnesses or injuries. No health hazard is indicated in the source; the recall addresses a quality issue.
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling Pantoprazole Sodium for Delayed-Release Oral Suspension (40 mg) nationwide due to product discoloration. The product is supplied as packets containing 40 mg pantoprazole suspended in apple juice or applesauce for oral administration.
The recall affects lot number MHC1317A (expiration 07/2023). Approximately 14,064 units (30 sachets per carton) were distributed nationwide in the USA. The product is distributed by Sun Pharmaceutical Industries, Inc. (Cranbury, NJ) and manufactured by Sun Pharmaceutical Industries Limited (Mohali, India).
This is a voluntary Class II recall initiated by the firm on July 25, 2022, and terminated on September 13, 2023.
The recalled product
- Product
- PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM)
- Brand
- PANTOPRAZOLE SODIUM
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Oral Suspension
- Hazard
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 #: MHC1317A
- Exp 07/2023
UPCs (1)
- 0362756071643
Distribution
Distributed nationwide across the United States.
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