Why it was recalled
Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold, was found floating in the product.
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Hospitals, clinics, physicians, and patients in the Michigan area only.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1156-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Oct 19, 2013
- FDA report date
- Mar 19, 2014
- Quantity
- 1000 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Specialty Medicine Compounding Pharmacy, P.C.
Original FDA data
Every field from FDA enforcement report D-1156-2014, exactly as published.
Show all FDA fields
- City
- South Lyon
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 67214
- Address
- 350 S Lafayette St
- 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
- Postal code
- 48178-1814
- Report date
- Mar 19, 2014
- Product type
- Drugs
- Recall number
- D-1156-2014
- Classification
- Class I
- Recalling firm
- Specialty Medicine Compounding Pharmacy, P.C.
- Product quantity
- 1000 vials
- Termination date
- Sep 22, 2014
- Reason for recall
- Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold, was found floating in the product.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Hospitals, clinics, physicians, and patients in the Michigan area only.
- Recall initiation date
- Oct 19, 2013
- Initial firm notification
- Press Release
- Center classification date
- Mar 12, 2014