Pantoprazole Sodium Tablets Recalled for CGMP Deviations and Discoloration
Hetero USA Inc. is recalling 2,352 bottles of Pantoprazole Sodium 40mg tablets due to manufacturing deviations that caused discoloration. The affected lot (PAN22542, exp. 9/2024) was distributed nationwide.
What this means for you
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: This is an FDA Class II recall for manufacturing quality deviations (discoloration), with no reported illnesses or injuries. Discoloration in a pharmaceutical product indicates a quality concern, but without explicit evidence of patient harm, it falls under moderate-risk precautionary recalls.
Plain-English summary
Hetero USA Inc. is recalling Pantoprazole Sodium Delayed Release Tablets USP 40mg in 1,000-count bottles due to deviations from Current Good Manufacturing Practice (CGMP) that resulted in discoloration of the tablets.
The affected product is distributed nationwide in the United States. The recall involves approximately 2,352 bottles from Lot #PAN22542 with an expiration date of September 2024. The product was manufactured for Camber Pharmaceuticals Inc. and is sold as a prescription medication.
Consumers who have purchased this medication should not use it and should consult their healthcare provider about an alternative. Healthcare providers should be aware of this recall when treating patients who may have received affected bottles.
The recalled product
- Product
- PANTOPRAZOLE SODIUM (PANTOPRAZOLE)
- Brand
- PANTOPRAZOLE SODIUM
- Manufacturer
- Hetero USA Inc
- Hazard
- cgmp-deviation
- discoloration
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 #: PAN22542
- Exp. Date: 9/2024
UPCs (2)
- 0331722713900
- 0331722712903
Distribution
Distributed nationwide across the United States.
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