FDA Recall D-1461-2014

Franck's Lab Inc dba Trinity Care Solutions · Ocala, FL

Class II Ongoing 4382 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

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

Quantity: 42 units

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.

Recall record

Recall number: D-1461-2014
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: Florida
Recall initiated: 2014-05-15
Classified by FDA Center: 2014-07-24
FDA published: 2014-07-30
Recalling firm: Franck's Lab Inc dba Trinity Care Solutions
Firm location: Ocala, FL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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