D-1156-2014 Class I Terminated
FDA drug recall D-1156-2014 was initiated by Specialty Medicine Compounding Pharmacy, P.C. on October 19, 2013 and is designated Class I. Reason for recall: Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold, was found floating in the product. The recall status is terminated (terminated September 22, 2014). Affected quantity: 1000 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- March 19, 2014
- Initiation Date
- October 19, 2013
- Termination Date
- September 22, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1000 vials
Product Description
Dextrose* Vial In Sterile Water, 50%, 50 mL Single Dose Vial, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Reason for Recall
Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold, was found floating in the product.
Distribution Pattern
Hospitals, clinics, physicians, and patients in the Michigan area only.
Code Information
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