Why it was recalled
Lack of Assurance of Sterility
Product description
All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TX
Lot numbers, UPCs & expiration codes
All unexpired lots of sterile drug products
Where it was sold
Nationwide and to Canada
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-1564-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 19, 2013
- FDA report date
- Sep 3, 2014
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Abrams Royal Pharamacy
Original FDA data
Every field from FDA enforcement report D-1564-2014, exactly as published.
Show all FDA fields
- City
- Dallas
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 67135
- Address
- 8220 Abrams Rd
- Code information
- All unexpired lots of sterile drug products
- Postal code
- 75231-1402
- Report date
- Sep 3, 2014
- Product type
- Drugs
- Recall number
- D-1564-2014
- Classification
- Class II
- Recalling firm
- Abrams Royal Pharamacy
- Termination date
- Oct 7, 2016
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TX
- Distribution pattern
- Nationwide and to Canada
- Recall initiation date
- Dec 19, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 25, 2014