Why it was recalled
cGMP Deviations: Potential glass contamination
Product description
Oxaliplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001, NDC 49821-0075-XX
Lot numbers, UPCs & expiration codes
Lot #: B0126-170701; B0126-170802; Exp. Sep 2022; B0126-180401, Exp. May 2023; B0126-180702, B0126-180803, Exp. Oct 2023
Where it was sold
Nationwide within 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-1882-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 29, 2019
- FDA report date
- Oct 2, 2019
- Quantity
- 316703.32
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Johnson Matthey Inc.
Original FDA data
Every field from FDA enforcement report D-1882-2019, exactly as published.
Show all FDA fields
- City
- West Deptford
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 83457
- Address
- 2003 Nolte Dr
- Code information
- Lot #: B0126-170701; B0126-170802; Exp. Sep 2022; B0126-180401, Exp. May 2023; B0126-180702, B0126-180803, Exp. Oct 2023
- Postal code
- 08066-1727
- Report date
- Oct 2, 2019
- Product type
- Drugs
- Recall number
- D-1882-2019
- Classification
- Class II
- Recalling firm
- Johnson Matthey Inc.
- Product quantity
- 316703.32
- Termination date
- Jan 21, 2022
- Reason for recall
- cGMP Deviations: Potential glass contamination
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Oxaliplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001, NDC 49821-0075-XX
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Aug 29, 2019
- Initial firm notification
- Letter
- Center classification date
- Sep 25, 2019