Recalls / Class III
Class IIID-1214-2018
Product
Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-541-01
- 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# S800232, Exp 2/20
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.
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
- 4716 bottle
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2018-08-23
- FDA classified
- 2018-09-27
- Posted by FDA
- 2018-09-26
- Terminated
- 2022-10-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1214-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.