Why it was recalled
Failed Impurities/Degradation Specifications
Product description
Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-118-03 UPC 343386118038
Lot numbers, UPCs & expiration codes
M16002A (02/2018); M16246A (04/2018); M16246B (04/2018); M16434A (07/2018); M16569A (10/2018); M17015A (01/2019); S700271 (04/2019);
Where it was sold
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-0599-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 5, 2018
- FDA report date
- Mar 21, 2018
- Quantity
- 134,364 bottles (4,030,920 tablets)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novel Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0599-2018, exactly as published.
Show all FDA fields
- City
- Somerset
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 79298
- Address
- 400 Campus Dr
- Code information
- M16002A (02/2018); M16246A (04/2018); M16246B (04/2018); M16434A (07/2018); M16569A (10/2018); M17015A (01/2019); S700271 (04/2019);
- Postal code
- 08873-1145
- Report date
- Mar 21, 2018
- Product type
- Drugs
- Recall number
- D-0599-2018
- Classification
- Class III
- Recalling firm
- Novel Laboratories, Inc.
- Product quantity
- 134,364 bottles (4,030,920 tablets)
- Termination date
- Jun 8, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-118-03 UPC 343386118038
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 5, 2018
- Initial firm notification
- Letter
- Center classification date
- Mar 14, 2018