Why it was recalled
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product description
Gentamicin 24mg/60ml Irrigation, 15x60ml Syr Irrigation, 14 day expiration,
Lot numbers, UPCs & expiration codes
All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
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-490-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 22, 2013
- FDA report date
- Jun 5, 2013
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nora Apothecary and Alternative Therapies, Inc.
Original FDA data
Every field from FDA enforcement report D-490-2013, exactly as published.
Show all FDA fields
- City
- Indianapolis
- State
- IN
- Status
- Terminated
- Country
- United States
- Event ID
- 65019
- Address
- 1101 E 86th St
- Code information
- All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
- Postal code
- 46240-3729
- Report date
- Jun 5, 2013
- Product type
- Drugs
- Recall number
- D-490-2013
- Classification
- Class II
- Recalling firm
- Nora Apothecary and Alternative Therapies, Inc.
- Termination date
- Aug 1, 2014
- Reason for recall
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Gentamicin 24mg/60ml Irrigation, 15x60ml Syr Irrigation, 14 day expiration,
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 22, 2013
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- May 29, 2013