Recalls / Class II
Class IID-1163-2015
Product
TPN 3:1, 1050 mL Bags, Qty: 6, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Sterile Water; Electrolytes KCL, K Phos, MgSO4, NaCl, Zinc Cl, Ca Gluconate; Vitamins, trace elements and medications Trace Ele.-Ped, Infuvite Pediat, Carnitor, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.
- Affected lot / code info
- All product compounded between May 14, 2015 and May 27, 2015
Why it was recalled
Lack of Assurance of Sterility: Sterility of product is not assured.
Recalling firm
- Firm
- Lincare, Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 1527 S Bowman Rd Ste D, Little Rock, Arkansas 72211-4200
Distribution
- Quantity
- 6 preparations
- Distribution pattern
- United States including: Arkansas
Timeline
- Recall initiated
- 2015-05-28
- FDA classified
- 2015-07-01
- Posted by FDA
- 2015-07-08
- Terminated
- 2017-02-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1163-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.