Why it was recalled
Lack of Assurance of Sterility: Sterility of product is not assured.
Product description
TPN 3:1, 2000 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Sterile Water; Electrolytes K Acetate, Na Acetate, Famotidine, Ca Gluconate, MgSO4, NaCl, Zinc Cl; Vitamins, trace elements and medications Salenium, Multi Vitamin, Vitamin K, Ascorbic Acid, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.
Lot numbers, UPCs & expiration codes
All product compounded between May 14, 2015 and May 27, 2015
Where it was sold
United States including: Arkansas
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-1154-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 28, 2015
- FDA report date
- Jul 8, 2015
- Quantity
- 7 Bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lincare, Inc.
Original FDA data
Every field from FDA enforcement report D-1154-2015, exactly as published.
Show all FDA fields
- City
- Little Rock
- State
- AR
- Status
- Terminated
- Country
- United States
- Event ID
- 71415
- Address
- 1527 S Bowman Rd Ste D
- Code information
- All product compounded between May 14, 2015 and May 27, 2015
- Postal code
- 72211-4200
- Report date
- Jul 8, 2015
- Product type
- Drugs
- Recall number
- D-1154-2015
- Classification
- Class II
- Recalling firm
- Lincare, Inc.
- Product quantity
- 7 Bags
- Termination date
- Feb 16, 2017
- Reason for recall
- Lack of Assurance of Sterility: Sterility of product is not assured.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- TPN 3:1, 2000 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Sterile Water; Electrolytes K Acetate, Na Acetate, Famotidine, Ca Gluconate, MgSO4, NaCl, Zinc Cl; Vitamins, trace elements and medications Salenium, Multi Vitamin, Vitamin K, Ascorbic Acid, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.
- Distribution pattern
- United States including: Arkansas
- Recall initiation date
- May 28, 2015
- Initial firm notification
- Telephone
- Center classification date
- Jul 1, 2015