Drug product
Lactated Ringer's Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7953-09.
D-0283-2015
Product summary
- Firm
- Hospira Inc.
- Event
- Event 69494
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,193,416 bags
- Official record key
drug-enforcement:D-0283-2015
Official wording
Reason: Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Code information: Lot # 32-099-JT; Exp. 08/15 Lot # 32-103-JT; Exp. 08/15 Lot # 34-070-JT; Exp. 10/15 Lot # 34-086-JT; Exp. 10/15 Lot # 34-165-JT; Exp. 10/15 Lot # 35-085-JT; Exp. 11/15 Lot # 35-115-JT; Exp. 11/15 Lot # 35-121-JT; Exp. 11/15 Lot # 36-057-JT; Exp. 12/15
Distribution pattern: Nationwide, Puerto Rico, and U.S. Virgin Islands.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility