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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot# S800232, Exp 2/20
Where it was sold
U.S.A. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1214-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 23, 2018
- FDA report date
- Sep 26, 2018
- Quantity
- 4716 bottle
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- LUPIN SOMERSET
Original FDA data
Every field from FDA enforcement report D-1214-2018, exactly as published.
Show all FDA fields
- City
- Somerset
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 80874
- Address
- 400 Campus Dr
- Code information
- Lot# S800232, Exp 2/20
- Postal code
- 08873-1145
- Report date
- Sep 26, 2018
- Product type
- Drugs
- Recall number
- D-1214-2018
- Classification
- Class III
- Recalling firm
- LUPIN SOMERSET
- Product quantity
- 4716 bottle
- Termination date
- Oct 14, 2022
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Aug 23, 2018
- Initial firm notification
- Letter
- Center classification date
- Sep 27, 2018