Why it was recalled
Lack of Assurance of Sterility .
Product description
All Sterile Products within expiry
Lot numbers, UPCs & expiration codes
Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products
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-0148-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 17, 2017
- FDA report date
- Dec 27, 2017
- Quantity
- 61 Products
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Vital Rx, Inc. dba Atlantic Pharmacy and Compounding
Original FDA data
Every field from FDA enforcement report D-0148-2018, exactly as published.
Show all FDA fields
- City
- Pompano Beach
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 77978
- Address
- 1000 E Atlantic Blvd Rm Ste 110
- Code information
- Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products
- Postal code
- 33060-7479
- Report date
- Dec 27, 2017
- Product type
- Drugs
- Recall number
- D-0148-2018
- Classification
- Class II
- Recalling firm
- Vital Rx, Inc. dba Atlantic Pharmacy and Compounding
- Product quantity
- 61 Products
- Termination date
- Apr 29, 2020
- Reason for recall
- Lack of Assurance of Sterility .
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- All Sterile Products within expiry
- Distribution pattern
- Nationwide.
- Recall initiation date
- Aug 17, 2017
- Initial firm notification
- Press Release
- Center classification date
- Jan 2, 2018