Morphine Sulfate Extended-Release Tablets recall: Impurity Out of Spec
Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873…
Why was Morphine Sulfate Extended-Release Tablets recalled?
Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impurity during 3 month stability analysis and during retain testing.
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# S800232, Exp 2/20
- Product
- Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873…
- Recalling firm
- LUPIN SOMERSET
- Quantity
- 4716 bottle
- Distribution
- U.S.A. Nationwide
- Recall date
- September 26, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)