Why it was recalled
Lack of Assurance of Sterility
Product description
Gentamicin 80mg/60 mL Irrigation, containers, The Medicine Shoppe, 3524 B Tamiami Trail Port Charlotte, FL 33952
Lot numbers, UPCs & expiration codes
7016542, discard after 01/12/2021
Where it was sold
Florida
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-1072-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 16, 2020
- FDA report date
- Apr 8, 2020
- Quantity
- 4 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Medicine Shoppe Pharmacy
Original FDA data
Every field from FDA enforcement report D-1072-2020, exactly as published.
Show all FDA fields
- City
- Port Charlotte
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 85234
- Address
- 3524 B Tamiami Trl
- Code information
- 7016542, discard after 01/12/2021
- Postal code
- 33952-8100
- Report date
- Apr 8, 2020
- Product type
- Drugs
- Recall number
- D-1072-2020
- Classification
- Class II
- Recalling firm
- The Medicine Shoppe Pharmacy
- Product quantity
- 4 bottles
- Termination date
- Dec 8, 2022
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Gentamicin 80mg/60 mL Irrigation, containers, The Medicine Shoppe, 3524 B Tamiami Trail Port Charlotte, FL 33952
- Distribution pattern
- Florida
- Recall initiation date
- Mar 16, 2020
- Initial firm notification
- Letter
- Center classification date
- Mar 31, 2020