CLASS I Drug recall · Reported 19 Mar 2014 · FDA Enforcement Report
Dextrose* Vial In Sterile Water, 50% Single Dose Vial recalled
Specialty Medicine Compounding Pharmacy, P.C is recalling Dextrose* Vial In Sterile Water, 50% Single Dose Vial, distributed in Michigan. The recall was initiated on 19 Oct 2013 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1156-2014
- FDA event ID
- 67214
- Recalling firm
- Specialty Medicine Compounding Pharmacy, P.C, South Lyon, MI
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 19 Oct 2013
- FDA classified
- 12 Mar 2014
- Reported
- 19 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Mold
- Drug class
- Injectable & IV Drugs
Timeline
| 19 Oct 2013 | Recall initiated by company | |
| 12 Mar 2014 | Classified by FDA | +144 days |
| 19 Mar 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold, was found floating in the product.
Product as listed by the FDA
Dextrose* Vial In Sterile Water, 50%, 50 mL Single Dose Vial, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Where it was distributed
Hospitals, clinics, physicians, and patients in the Michigan area only.
Questions about this recall
Why was it recalled?
Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold, was found floating in the product.
Which lots are affected?
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 was it sold?
Hospitals, clinics, physicians, and patients in the Michigan area only.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.