US Drug Recall Register
Class II · Moderate risk Ongoing Initiated May 15, 2014 (12 years ago)

Cefepime 1 gm/100 mL 0.9%NS

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was 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.

What was recalled

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

Recalling firm
Franck's Lab Inc dba Trinity Care Solutions
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1479-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Cefepime recalls

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Class II · Moderate risk Terminated

Cefepime for Injection

Reason Lack of Assurance of Sterility

Astral SteriTech Private Ltd. NDC 70594-090-02 D-0610-2023
Class II · Moderate risk Terminated

Cefepime for Injection

Reason Lack of Assurance of Sterility

Astral SteriTech Private Ltd. NDC 70594-089-02 D-0609-2023
Class II · Moderate risk Terminated

Cefepime for Injection

Reason Lack of Assurance of Sterility

Astral SteriTech Private Ltd. NDC 66794-210-41 D-0608-2023
Class II · Moderate risk Terminated

Cefepime for Injection

Reason Lack of Assurance of Sterility

Astral SteriTech Private Ltd. NDC 66794-209-41 D-0607-2023
Class II · Moderate risk Terminated

Cefepime for Injection

Reason Lack of Assurance of Sterility

Astral SteriTech Private Ltd. NDC 71288-009-20 D-0606-2023