Recalls / Class II
Class IID-1156-2015
Product
TPN 3:1, 997 ml without lipids Bags, Qty: 3, Base Formula Dextrose 70%, Travasol 10%, Water for Inj; Electrolytes K Acetate, Na Acetate, KCL, Na Phos, Ca Gluconate, MgSO4, NaCl, Zinc Cl; Vitamins, trace elements and medications Selenium, Copper Cl, Carnitor, Infuvitm Pediat, 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
- 3 Bags
- 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-1156-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.