Drug product
Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-1207-13), Rx only, Manufactured by Hospira, Inc, Lake Forest, IL 60046 USA.
D-686-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 65226
- Status
- Terminated
- Classification
- Class II
- Quantity
- 168,300 vals
- Official record key
drug-enforcement:D-686-2013
Official wording
Reason: Presence of Particulate Matter: visible particles were identified floating in the primary container.
Code information: Lot 07-067-DK Exp. 07/13
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter