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Recall Observatory FDA recall evidence

Drug 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

D-1363-2014

April 09, 2014

Class II

Product summary

Firm
Legacy Pharmaceutical Packaging
Event
Event 67978
Status
Terminated
Classification
Class II
Quantity
unknown
Official record key
drug-enforcement:D-1363-2014

Official wording

Reason: Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Release may contain correctly labeled blister cards of Lorazepam tablets

Code information: No lot or expiration date is displayed on this carton.

Distribution pattern: IN

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Release may contain correctly labeled blister cards of Lorazepam tablets