Multi-event May 2014 FDA Recall Drug by Franck's Lab Inc Dba Trinity Care Solutions

This Multi-event Class II drug recall was voluntarily initiated by Franck's Lab Inc Dba Trinity Care Solutions on May 15, 2014 for the product Drug. The FDA reported the reason for recall as 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.. The product was distributed in Florida and the recall is currently ongoing.

Reported Recall Events

Recall Number: D-1471-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity
14 units

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Tobramycin 300 mg/7.5 mL Syringe (for Neb), Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28503, Discard After 02/27/14

Batch or Lot Expiration Information

Lot# Rx # 28503, Exp 02/27/14

Recall Number: D-1476-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity
10 units

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Cubicin 543 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29175, Discard After 05/21/14; Rx # 28830, Discard After 05/17/14

Batch or Lot Expiration Information

Lot# Rx # 29175, Exp 05/21/14; Rx # 28830, Exp 05/17/14

Recall Number: D-1467-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity
1 unit

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Cubicin 444 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29114, Discard After 05/13/14

Batch or Lot Expiration Information

Lot# Rx # 29114, Exp 05/13/14

Recall Number: D-1470-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity
1 unit

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
ANA Kit, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28838, Discard After 03/4/15

Batch or Lot Expiration Information

Lot# Rx # 28838, Exp 03/4/15

Recall Number: D-1482-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity
12 units

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Ceftriaxone 1 gm/50 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29190, Discard After 05/23/14, Rx # 29068, Exp 05/18/14

Batch or Lot Expiration Information

Lot# Rx # 29190, Exp 05/23/14; Rx # 29068, Exp 05/18/14

Recall Number: D-1454-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity
22 units

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Vancomycin 750 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28289, Discard After 02/5/14; Rx # 29189, Discard After 05/23/14

Batch or Lot Expiration Information

Lot# Rx # 28289, Exp 02/5/14; Rx # 29189, Exp 05/23/14

Recall Number: D-1478-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity
7 units

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Cubicin 700 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29083, Discard After 05/21/14

Batch or Lot Expiration Information

Lot# Rx # 29083, Exp 05/21/14

Recall Number: D-1453-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity
7 units

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Levofloxacin 750 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx #29184, Discard After 05/28/14

Batch or Lot Expiration Information

Lot# Rx 29184 Exp 5/28/14

Recall Number: D-1456-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity
6 units

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Desferal 2.5 gm/14 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, Rx # 28314, Discard After 05/22/14

Batch or Lot Expiration Information

Lot# Rx 28314 Exp 5/22/2014

Recall Number: D-1458-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity
31 units

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Ceftriaxone 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, RX # 29038, Discard After 05/05/14, & 05/20/14; RX # 29204, Discard After 05/23/14; RX # 29161, Discard After 05/19/14

Batch or Lot Expiration Information

Lot# Rx # 29039, Exp 05/05/14 & 05/20/14; Rx # 29204, Exp 05/23/14; Rx # 29161, Exp 05/19/14

Recall Number: D-1474-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity
16 units

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Vancomycin 750 mg/150mL D5W,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28878, Discard After 05/16/14

Batch or Lot Expiration Information

Lot# Rx # 28878, Exp 05/16/14

Recall Number: D-1472-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity
21 units

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Vancomycin 1 gm/100 mL 0.9%NS,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29186, Discard After 05/22/14; Rx # 29010, Discard After 05/22/14

Batch or Lot Expiration Information

Lot# Rx # 29186, Exp 05/22/14; Rx # 29010, Exp 05/22/14

Recall Number: D-1481-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity
11 units

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Cefepime 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28879, Discard After 05/21/14

Batch or Lot Expiration Information

Lot# Rx # 28879, Exp 05/21/14

Recall Number: D-1466-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity
21 units

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Cefazolin 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28837, Discard After 04/11/14

Batch or Lot Expiration Information

Lot# Rx # 28837, Exp 04/11/14

Recall Number: D-1477-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity
8 units

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Cubicin 600 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29096, Discard After 05/20/14

Batch or Lot Expiration Information

Lot# Rx # 29096, Exp 05/20/14

Recall Number: D-1465-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity
21 units

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Impipenem/Cilastin (Primaxin) 500 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx #28694, Discard After 05/22/14

Batch or Lot Expiration Information

Lot# Rx #28694, Exp 05/22/14

Recall Number: D-1455-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity
7 units

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Pfizerpen (penicillin G) 24 MU/300 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29183, Discard After 05/21/14

Batch or Lot Expiration Information

Lot# Rx 29183 Exp, 5/21/2014

Recall Number: D-1463-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity
60 units

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Unasyn (ampicillin/sulbactam) 1.5 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29082, Discard After 05/19/14

Batch or Lot Expiration Information

Lot# Rx # 29082 Exp. 5/19/14

Recall Number: D-1464-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity
2 units

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Desferal 2 gm/8 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 27767, Discard After 05/23/14

Batch or Lot Expiration Information

Lot# Rx # 27767, Exp 05/23/14

Recall Number: D-1475-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity
14 units

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Vancomycin 1.25 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29185, Discard After 05/23/14

Batch or Lot Expiration Information

Lot# Rx # 29185, Exp 05/23/14

Recall Number: D-1457-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity
24 units

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Cefepime 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28288, Discard After 02/4/14; Rx # 29176, Discard After 05/21/14; Rx # 28829, Discard After 05/17/14

Batch or Lot Expiration Information

Lot# Rx # 28288, Exp 02/4/14; Rx # 29176, Exp 05/21/14; Rx # 28829, Exp 05/17/14

Recall Number: D-1468-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Normal Saline 10 mL/10 mL Syringe, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, Rx # 28839, Discard After 05/5/15; Rx # 29163, Discard After 05/8/15

Batch or Lot Expiration Information

Lot# Rx # 28839, Exp 05/5/15; Rx # 29136, Exp 05/8/15

Recall Number: D-1469-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity
7 units

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Ambisome 285 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28300, Discard After 02/7/14

Batch or Lot Expiration Information

Lot# Rx # 28300, Exp 02/7/14

Recall Number: D-1462-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity
5 units

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Nafcillin 12 gm/300 mL, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29162, Discard After 05/21/14

Batch or Lot Expiration Information

Lot# Rx 29162 Exp. 5/21/2014

Recall Number: D-1459-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity
7

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Cubicin 486 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, RX # 29038, Discard After 05/20/2014

Batch or Lot Expiration Information

Lot# Rx # 29038, Exp 05/20/14

Recall Number: D-1479-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity
52 units

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Cefepime 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29011, Discard After 05/21/14, Rx # 29141, Discard After 05/22/14, Rx # 29171, Discard After 05/20/14

Batch or Lot Expiration Information

Lot# Rx # 29011, Exp 05/21/14; Rx # 29141, Exp 05/22/14; Rx # 29171, Exp 05/20/14

Recall Number: D-1480-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity
5 units

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Ceftriaxone 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29150, Discard After 05/17/14

Batch or Lot Expiration Information

Lot# Rx # 29150, Exp 05/17/14

Recall Number: D-1460-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity
12 units

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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

Batch or Lot Expiration Information

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

Recall Number: D-1461-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity
42 units

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Meropenem 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29087, Discard After 05/28/14

Batch or Lot Expiration Information

Lot# Rx # 29087 Exp. 5/28/2014

Recall Number: D-1473-2014

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.
Initiated
05-15-2014
Reported
07-30-2014
Quantity
14 units

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc dba Trinity Care Solutions
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Vancomycin 1.25 gm/250 mL 0.9%NS,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29140, Discard After 05/23/14

Batch or Lot Expiration Information

Lot# Rx # 29140, Exp 05/23/14