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
Reported: July 30, 2014 Initiated: May 15, 2014 #D-1460-2014
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.
Details
- Recalling Firm
- Franck's Lab Inc dba Trinity Care Solutions
- Units Affected
- 12 units
- Distribution
- Florida
- Location
- Ocala, FL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Franck's Lab Inc dba Trinity Care Solutions. Units affected: 12 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 30, 2014. Severity: Moderate. Recall number: D-1460-2014.
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