D-686-2013 Class II Terminated
FDA drug recall D-686-2013 was initiated by Hospira Inc. on May 2, 2013 and is designated Class II. Reason for recall: Presence of Particulate Matter: visible particles were identified floating in the primary container. The recall status is terminated (terminated Oct 28, 2014). Affected quantity: 168,300 vals.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 17, 2013
- Initiation Date
- May 2, 2013
- Termination Date
- Oct 28, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 168,300 vals
Product Description
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.
Reason for Recall
Presence of Particulate Matter: visible particles were identified floating in the primary container.
Distribution Pattern
Nationwide
Code Information
Lot 07-067-DK Exp. 07/13
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-686-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026