Home / Recalls / Franck's Lab Inc dba Trinity Care Solutions / D-1460-2014

D-1460-2014 Class II Ongoing

Recalled by Franck's Lab Inc dba Trinity Care Solutions — Ocala, FL

Recall Details

Product Type
Drugs
Report Date
July 30, 2014
Initiation Date
May 15, 2014
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12 units

Product Description

Invanz (ertapenem)1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29157, Discard After 05/19/14; Rx # 29097, Discard After 05/20/14

Reason for Recall

Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.

Distribution Pattern

Florida

Code Information

Rx # 29157, Exp 5/19/14; Rx # 29097, Exp 5/20/14

Other recalls by Franck's Lab Inc dba Trinity Care Solutions

  • D-1453-2014 Class II — Levofloxacin 750 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Oc (May 15, 2014)
  • D-1472-2014 Class II — Vancomycin 1 gm/100 mL 0.9%NS,Trinity Care Solutions, 202-C SW 17th Street, Ocal (May 15, 2014)
  • D-1481-2014 Class II — Cefepime 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala (May 15, 2014)
  • D-1466-2014 Class II — Cefazolin 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocal (May 15, 2014)
  • D-1477-2014 Class II — Cubicin 600 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocal (May 15, 2014)
  • D-1465-2014 Class II — Impipenem/Cilastin (Primaxin) 500 mg/100 mL 0.9%NS, Trinity Care Solutions, 202- (May 15, 2014)
  • D-1455-2014 Class II — Pfizerpen (penicillin G) 24 MU/300 mL 0.9%NS, Trinity Care Solutions, 202-C SW 1 (May 15, 2014)
  • D-1463-2014 Class II — Unasyn (ampicillin/sulbactam) 1.5 gm/100 mL 0.9%NS, Trinity Care Solutions, 202- (May 15, 2014)
  • D-1464-2014 Class II — Desferal 2 gm/8 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th Street, (May 15, 2014)
  • D-1467-2014 Class II — Cubicin 444 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocal (May 15, 2014)