D-0835-2020 Class II Terminated
FDA drug recall D-0835-2020 was initiated by Pfizer Inc. on February 3, 2020 and is designated Class II. Reason for recall: Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility. The recall status is terminated (terminated September 29, 2022). Affected quantity: 38,676 trays.
Recall Details
- Product Type
- Drugs
- Report Date
- February 19, 2020
- Initiation Date
- February 3, 2020
- Termination Date
- September 29, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38,676 trays
Product Description
Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intravenous or Intramuscular Use, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045, NDC 00409-9094-12 (vial), 00409-9094-22 (tray).
Reason for Recall
Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.
Distribution Pattern
Nationwide in the U.S. and Puerto Rico
Code Information
Lot #s: 08133DK (tray) 08-133-DK (vial); 08134DK (tray) 08-134-DK (vial), Exp. 2/1/2021.