Reported Sep 26, 2018 · Terminated
Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc.…
Lupin Somerset
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LUPIN SOMERSET · 400 Campus Dr · Somerset, NJ · 08873-1145
Is this the product you have?
- Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only
- Manufactured byNovel Laboratories, Inc. Somerset, NJ 08873
- Manufactured forLupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-541-01
- Lot codes and dates
Lot# S800232Exp 2/20
- Amount recalled
- 4716 bottle
Where it was sold
- Nationwide
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Lupin Somerset recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.