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Class II: temporary or reversible health riskTerminated

Hospira Gentamicin Sulfate Injection 80 mg/2 mL(40 Recall

Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose F…

Hospira Inc. · Lake Forest, IL

Risk level
Class II
Reported by FDA
Jul 17, 2013
Recall ID
D-686-2013
Check your lot numberHow we source this data

Summary

Hospira recalled Gentamicin Sulfate Injection 80 mg/2 mL(40 starting May 2, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-686-2013 on Jul 17, 2013. Reason: Presence of Particulate Matter: visible particles were identified floating in the primary container. Status: Terminated.

Why it was recalled

Presence of Particulate Matter: visible particles were identified floating in the primary container.

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.

Lot numbers, UPCs & expiration codes

Lot 07-067-DK Exp. 07/13

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-686-2013
Classification
Class II
Status
Terminated
Recall initiated
May 2, 2013
FDA report date
Jul 17, 2013
Quantity
168,300 vals
Recall type
Voluntary: Firm initiated
Recalling firm
Hospira Inc.

Original FDA data

Every field from FDA enforcement report D-686-2013, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
65226
Address
275 N Field Dr
Code information
Lot 07-067-DK Exp. 07/13
Postal code
60045-2579
Report date
Jul 17, 2013
Product type
Drugs
Recall number
D-686-2013
Classification
Class II
Recalling firm
Hospira Inc.
Product quantity
168,300 vals
Termination date
Oct 28, 2014
Reason for recall
Presence of Particulate Matter: visible particles were identified floating in the primary container.
Voluntary / mandated
Voluntary: Firm initiated
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.
Distribution pattern
Nationwide
Recall initiation date
May 2, 2013
Initial firm notification
Letter
Center classification date
Jul 8, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-686-2013, published Jul 17, 2013. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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