Why it was recalled
Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis
Product description
MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX
Lot numbers, UPCs & expiration codes
Lot number 11142013@74
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-1563-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 19, 2013
- FDA report date
- Sep 3, 2014
- Quantity
- 74
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Abrams Royal Pharamacy
Original FDA data
Every field from FDA enforcement report D-1563-2014, 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
- Lot number 11142013@74
- Postal code
- 75231-1402
- Report date
- Sep 3, 2014
- Product type
- Drugs
- Recall number
- D-1563-2014
- Classification
- Class I
- Recalling firm
- Abrams Royal Pharamacy
- Product quantity
- 74
- Termination date
- Oct 7, 2016
- Reason for recall
- Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- MINERAL IV Injection, 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