The Recall Desk
HighFDA (Drugs)·D-1363-2014·Announced 2014-06-18

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.

What this means for you

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

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:

Same manufacturer · Legacy Pharmaceutical Packaging

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