FDAClass IIIMay 1, 2019

Morphine Sulfate Extended-Release Tablets recall: Impurity Out of Spec

Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for…

Why was Morphine Sulfate Extended-Release Tablets recalled?

Failed Impurities/Degradation Specifications

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#: S700224 Exp. Apr 30 2019; S800469 Exp. Mar 31 2020

Product
Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for…
Recalling firm
LUPIN SOMERSET
Quantity
324 bottles
Distribution
Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
Recall date
May 1, 2019
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls