Dextrose* Vial In Sterile Water, 50%, 50 mL Single Dose Vial, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
This recall has been terminated (originally issued March 19, 2014).
- Recall Initiated
- October 19, 2013
- Posted
- March 19, 2014
- Recall Number
- D-1156-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1000 vials
- Firm Location
- South Lyon, MI, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold, was found floating in the product.
Distribution
Hospitals, clinics, physicians, and patients in the Michigan area only.
Lot / Code Info
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