Recalls / Class II
Class IID-0285-2021
Product
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.
- Affected lot / code info
- 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
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.
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
- 705,745 vials
- Distribution pattern
- Product was distributed nationwide in the USA and Puerto Rico.
Timeline
- Recall initiated
- 2021-02-10
- FDA classified
- 2021-02-21
- Posted by FDA
- 2021-03-03
- Terminated
- 2024-05-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0285-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.