Why it was recalled
Failed Impurities/Degradation Specifications
Product description
Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles, 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#: S700221, Exp. Apr 30 2019; S700605, Exp. July 31 2019; S800232, Exp. Feb 29 2020.
Where it was sold
Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
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-1244-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 10, 2019
- FDA report date
- May 1, 2019
- Quantity
- 15,320 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- LUPIN SOMERSET
Original FDA data
Every field from FDA enforcement report D-1244-2019, exactly as published.
Show all FDA fields
- City
- Somerset
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 82581
- Address
- 400 Campus Dr
- Code information
- Lot#: S700221, Exp. Apr 30 2019; S700605, Exp. July 31 2019; S800232, Exp. Feb 29 2020.
- Postal code
- 08873-1145
- Report date
- May 1, 2019
- Product type
- Drugs
- Recall number
- D-1244-2019
- Classification
- Class III
- Recalling firm
- LUPIN SOMERSET
- Product quantity
- 15,320 bottles
- Termination date
- Oct 14, 2022
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-541-01
- Distribution pattern
- Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
- Recall initiation date
- Apr 10, 2019
- Initial firm notification
- Letter
- Center classification date
- Apr 25, 2019