FDA Recall D-787-2013

Lowlite Investments, Inc. D/B/A Olympia Pharmacy · Orlando, FL

Class II Ongoing 4733 days on record

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

Product

Trimix, compounded by Olympia Pharmacy, Orlando, FL

Lot / code: B5015 Exp 8/15/13, C50001 Exp 8/28/13, B5011 Exp 8/1/13, C42215 Exp 6/22/13, A5028 Exp 6/2/13, B5011 Exp 6/1/13, B5020 Exp 6/1/13, B50112 Exp 8/11/13, C4186 Exp 6/18/13, C4158 Exp 6/15/13, C4149 Exp 6/14/13, C4111 Exp 6/11/13, B4124 Exp 8/12/13, B4154 Exp 8/15/13, B4198 Exp 8/19/13, B4226 Exp 8/22/13, B4268 Exp 8/22/13, C40522 Exp 9/5/13, C4118 Exp 9/1/13, C4711 Exp 9/7/13, C41121 Exp 9/11/13, C4126 Exp 9/12/13 and B42715 Exp 8/27/13.

Quantity: 24

Reason for recall

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Recall record

Recall number: D-787-2013
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: Nationwide and PR
Recall initiated: 2013-05-29
Classified by FDA Center: 2013-07-11
FDA published: 2013-07-17
Recalling firm: Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Firm location: Orlando, 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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