FDAClass IIJanuary 4, 2017

Nadolol Tablets recall: Failed Dissolution

Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10

Why was Nadolol Tablets recalled?

Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot GG1539

Product
Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10
Recalling firm
Sandoz Incorporated
Quantity
96 bottles
Distribution
MS and OH.
Recall date
January 4, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls