Pantoprazole Sodium Tablets Recalled Due to Potential Mispackaging with Lorazepam
Legacy Pharmaceutical Packaging is recalling Pantoprazole Sodium tablets because some cartons may contain Lorazepam tablets instead.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medication mispackaging) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Legacy Pharmaceutical Packaging is recalling Pantoprazole Sodium, Delayed-release tablets, USP, 40 mg tablets, 100 (10x10) unit dose packages. The product is manufactured by Dr. Reddy's Laboratories Limited, India, and distributed by Major Pharmaceuticals, Livonia, MI, under NDC 0904-6235-61.
The recall is due to a mispackaging issue where some cartons labeled as Pantoprazole Sodium Delayed-Release may contain correctly labeled blister cards of Lorazepam tablets. No lot or expiration date is displayed on the affected cartons.
Consumers and healthcare providers should check their inventory for this specific product and stop using it if it is found. They should contact the recalling firm for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Pantoprazole Sodium, Delayed-release tablets, USP, 40 mg tablets, 100 (10x10) unit dose packages, Manufactured by Dr. Reddy's Laboratories Limited, India and Distributed by Major Pharmaceuticals, Livonia, MI --- NDC 0904-6235-61
- Manufacturer
- Legacy Pharmaceutical Packaging
- Category
- Drug — Tablets
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)
- No lot or expiration date is displayed on this carton.
Distribution
Distributed in 1 state:
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