FDA Recall D-737-2013

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

Guanabenz 8 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL

Lot / code: C3621 Exp 9/21/13, L3618 Exp 10/31/13, and A0224 Exp 6/30/13

Quantity: 3

Reason for recall

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

Recall record

Recall number: D-737-2013
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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