Why it was recalled
Out-of-specification impurity test result observed at 18-month long term stability time point.
Product description
Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-432-01
Lot numbers, UPCs & expiration codes
Lot # S000268, Exp. date January 2022
Where it was sold
Product Distributed in NY and OH.
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-0358-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 29, 2021
- FDA report date
- Jan 12, 2022
- Quantity
- 23,965 100 count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0358-2022, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 89324
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot # S000268, Exp. date January 2022
- Postal code
- 21202-6174
- Report date
- Jan 12, 2022
- Product type
- Drugs
- Recall number
- D-0358-2022
- Classification
- Class III
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 23,965 100 count bottles
- Termination date
- Aug 23, 2022
- Reason for recall
- Out-of-specification impurity test result observed at 18-month long term stability time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-432-01
- Distribution pattern
- Product Distributed in NY and OH.
- Recall initiation date
- Dec 29, 2021
- Initial firm notification
- Letter
- Center classification date
- Jan 5, 2022