Recalls / Class II
Class IID-686-2013
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.
- Brand name
- Gentamicin Sulfate
- Generic name
- Gentamicin Sulfate
- Active ingredient
- Gentamicin Sulfate
- Route
- Intramuscular, Intravenous
- NDC
- 0409-1207
- FDA application
- ANDA062420
- Affected lot / code info
- Lot 07-067-DK Exp. 07/13
Why it was recalled
Presence of Particulate Matter: visible particles were identified floating in the primary container.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 168,300 vals
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-05-02
- FDA classified
- 2013-07-08
- Posted by FDA
- 2013-07-17
- Terminated
- 2014-10-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-686-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.