FDA Recalls Dextrose Vials Due to Mold Contamination
Specialty Medicine Compounding Pharmacy is recalling 50% Dextrose vials after mold was found in the product. The recall affects 1,000 vials distributed in Michigan.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which indicates a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death. The presence of mold in a sterile injectable product is a critical safety hazard.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Dextrose Vial In Sterile Water, 50%, 50 mL Single Dose Vials. The recall was initiated after particulate matter, later identified as mold, was found floating in the product. This indicates a non-sterility issue with the medication.
The recalled product was manufactured and distributed by Specialty Medicine Compounding Pharmacy, P.C., located in South Lyon, Michigan. The recall covers 1,000 vials, including all unexpired lots manufactured and distributed between July 1, 2013, and October 19, 2013. Specific lot numbers and expiration dates are listed in the official recall notice.
The product was distributed to hospitals, clinics, physicians, and patients in the Michigan area only. Consumers and healthcare providers should stop using the recalled vials and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- 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
- Manufacturer
- Specialty Medicine Compounding Pharmacy, P.C.
- Affected units
- 1,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed in 1 state:
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