Drug product
Lactated Ringer's Injection, USP, 1000 mL, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09
D-215-2013
Product summary
- Firm
- Hospira, Inc.
- Event
- Event 63242
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,296 units
- Official record key
drug-enforcement:D-215-2013
Official wording
Reason: CGMP Deviations: Shipment of product not approved for release.
Code information: Lot 16-836-FW, Exp 04/14
Distribution pattern: NC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations