Why it was recalled
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Product description
Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Teva Parenteral Medicines, Inc., Irvine, CA 92618, and b) Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, novaplus+, NDC 0703-5145-01.
Lot numbers, UPCs & expiration codes
Lot # a) 31324653B, exp. date 03/2021; 31326066B, exp. date 11/2021; 31326428B, exp. date 02/2022; 31327949B, exp. date 10/2022; 31327995B, exp. date 10/2022; 31328031B, exp. date 11/2022; 31328217B, exp. date 12/2022; 31328325B, exp. date 12/2022; 31328425B, exp. date 07/2021; Lot # b) 31324480B, exp. date 02/2021; Lot # 31327396B, exp. date 08/2022
Where it was sold
Product was distributed nationwide in the USA and Puerto Rico.
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-0285-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 10, 2021
- FDA report date
- Mar 3, 2021
- Quantity
- 705,745 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0285-2021, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 87298
- Address
- 400 Interpace Pkwy
- Code information
- Lot # a) 31324653B, exp. date 03/2021; 31326066B, exp. date 11/2021; 31326428B, exp. date 02/2022; 31327949B, exp. date 10/2022; 31327995B, exp. date 10/2022; 31328031B, exp. date 11/2022; 31328217B, exp. date 12/2022; 31328325B, exp. date 12/2022; 31328425B, exp. date 07/2021; Lot # b) 31324480B, exp. date 02/2021; Lot # 31327396B, exp. date 08/2022
- Postal code
- 07054-1120
- Report date
- Mar 3, 2021
- Product type
- Drugs
- Recall number
- D-0285-2021
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 705,745 vials
- Termination date
- May 15, 2024
- Reason for recall
- Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Teva Parenteral Medicines, Inc., Irvine, CA 92618, and b) Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, novaplus+, NDC 0703-5145-01.
- Distribution pattern
- Product was distributed nationwide in the USA and Puerto Rico.
- Recall initiation date
- Feb 10, 2021
- Initial firm notification
- Letter
- Center classification date
- Feb 21, 2021