Drug product
Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02
D-0218-2017
Product summary
- Event
- Event 74925
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 143,250 vials
- Official record key
drug-enforcement:D-0218-2017
Official wording
Reason: Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
Code information: Lot # 59064DK, Exp. 11/17
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
particulate matter