Reported May 1, 2019 · Terminated
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories,…
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, 100 mg, 100-count bottles, Rx Only
- Manufactured byNovel Laboratories, Inc. Somerset
- NJ 08873 Manufactured forLupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-543-01
- Lot codes and dates
Lot#: S700223 Exp. Apr 30 2019S800467Exp. Mar 31 2020
- Amount recalled
- 3,444 bottles
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Why it was recalled
Failed Impurities/Degradation Specifications
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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