Recalls / Class II
Class IID-0374-2021
Product
Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile, Teva Parenteral Medicines, Inc., Irvine, CA NDC 0703-5145-01; ALSO LABELED UNDER: NOVAPLUS, Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-5145-91 (Novaplus, a registered trademark of Vizient, Inc.)
- Affected lot / code info
- NDC 0703-5145-01: Lot # 31325332B, exp. date 08/2021, Lot # 31325756B, exp. date 09/2021 AND NDC 0703-5145-91: Lot # 31325685B, exp. date 09/2021
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 192,277 cartons/1 single dose vial per carton
- Distribution pattern
- Product was distributed nationwide.
Timeline
- Recall initiated
- 2021-04-26
- FDA classified
- 2021-05-14
- Posted by FDA
- 2021-05-26
- Terminated
- 2024-06-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0374-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.