FDA Recall D-1156-2014

Specialty Medicine Compounding Pharmacy, P.C. · South Lyon, MI

Class I — life-threatening Terminated 338 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

Dextrose* Vial In Sterile Water, 50%, 50 mL Single Dose Vial, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Lot / code: All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 07222013@19, 07222013@22, 07222013@23, 07222013@24, Exp 10/20/13; 07232013@1, 07232013@2, 07232013@3, 07232013@5, Exp 10/21/13; 07252013@1, 07252013@3, 07252013@4, 07252013@5, Exp 10/23/13; 07302013@24, 07302013@28, 07302013@30, 07302013@31, 07302013@32, Exp 10/28/13; 08052013@4, 08052013@6, 08052013@7, 08052013@8, 08052013@9, 08052013@10, Exp 11/03/13; 08092013@1, 08092013@8, 08092013@3, 08092013@4, 08092013@5, 08092013@6, Exp 11/07/13; 08122013@1, 08122013@3, 08122013@4, 08122013@5, 08122013@6, 08122013@7, Exp 11/10/13; 08162013@1, 08162013@3, 08162013@4, Exp 11/14/13; 08192013@2, 08192013@4, Exp 11/17/13

Quantity: 1000 vials

Reason for recall

Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold, was found floating in the product.

Recall record

Recall number: D-1156-2014
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Hospitals, clinics, physicians, and patients in the Michigan area only.
Recall initiated: 2013-10-19
Classified by FDA Center: 2014-03-12
FDA published: 2014-03-19
Terminated: 2014-09-22
Recalling firm: Specialty Medicine Compounding Pharmacy, P.C.
Firm location: South Lyon, MI

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