Teva Pharmaceuticals USA: Drug Recall
Recall #D-0285-2021 · 02/10/2021
Class II: Risk
Recall Details
- Recall Number
- D-0285-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Teva Pharmaceuticals USA
- Status
- Terminated
- Date Initiated
- 02/10/2021
- Location
- Parsippany, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 705,745 vials
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.
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.
Other Recalls by Teva Pharmaceuticals USA
- Class II: Risk 01/18/2022
- Class II: Risk 01/10/2022
- Class III: Low Risk 01/07/2022
- Class III: Low Risk 01/07/2022
- Class II: Risk 12/31/2021
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.