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Class III: unlikely to cause harmTerminated

Stat Rx Tobramycin Ophthalmic Oint Recall

Tobramycin Ophthalmic Oint

Stat Rx USA · Gainesville, GA

Risk level
Class III
Reported by FDA
Nov 21, 2012
Recall ID
D-050-2013
Check your lot numberHow we source this data

Summary

Stat Rx recalled Tobramycin Ophthalmic Oint starting Jun 18, 2012. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-050-2013 on Nov 21, 2012. Reason: Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution.". Status: Terminated.

Why it was recalled

Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."

Product description

Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake Forest, IL 60045, NDC 16590-224-05,

Lot numbers, UPCs & expiration codes

Lot 06JN1265 Exp 3/14 and 06JN1266 Exp 4/14

Where it was sold

FL, PA, and VA.

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-050-2013
Classification
Class III
Status
Terminated
Recall initiated
Jun 18, 2012
FDA report date
Nov 21, 2012
Quantity
22 units
Recall type
Voluntary: Firm initiated
Recalling firm
Stat Rx USA

Original FDA data

Every field from FDA enforcement report D-050-2013, exactly as published.

Show all FDA fields
City
Gainesville
State
GA
Status
Terminated
Country
United States
Event ID
62940
Address
2481 Hilton Dr
Code information
Lot 06JN1265 Exp 3/14 and 06JN1266 Exp 4/14
Postal code
30501-6213
Report date
Nov 21, 2012
Product type
Drugs
Recall number
D-050-2013
Classification
Class III
Recalling firm
Stat Rx USA
Product quantity
22 units
Termination date
Jan 31, 2013
Reason for recall
Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."
Voluntary / mandated
Voluntary: Firm initiated
Product description
Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake Forest, IL 60045, NDC 16590-224-05,
Distribution pattern
FL, PA, and VA.
Recall initiation date
Jun 18, 2012
Initial firm notification
E-Mail
Center classification date
Nov 9, 2012

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-050-2013, published Nov 21, 2012. View the source record (openFDA) · FDA enforcement reports

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

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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