Recalls / Class III
Class IIID-1243-2019
Product
Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-540-01
- Brand name
- Morphine Sulfate
- Generic name
- Morphine Sulfate
- Active ingredient
- Morphine Sulfate
- Route
- Oral
- NDCs
- 43386-540, 43386-541, 43386-542, 43386-543, 43386-544
- FDA application
- ANDA203602
- Affected lot / code info
- Lot#: S700220, Exp. Apr 30 2019; S700604, Exp. July 31 2019; S800326, Exp. Mar 31 2020
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- LUPIN SOMERSET
- Manufacturer
- Lupin Pharmaceuticals,Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Campus Dr, N/A, Somerset, New Jersey 08873-1145
Distribution
- Quantity
- 17,328 bottles
- Distribution pattern
- Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
Timeline
- Recall initiated
- 2019-04-10
- FDA classified
- 2019-04-25
- Posted by FDA
- 2019-05-01
- Terminated
- 2022-10-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1243-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.