McGuff Compounding Pharmacy Recalls DMPS Injection Due to Particulate Matter
McGuff Compounding Pharmacy Services, Inc. is recalling Dimercaptopropanesulfonate Sodium (DMPS) injection vials due to the presence of particulate matter.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
McGuff Compounding Pharmacy Services, Inc. is recalling Dimercaptopropanesulfonate Sodium (DMPS), Aqueous injection solution, 50mg/mL 5 mL SDV, Rx only. The recall is being conducted because particulates were observed in vials released for dispensing.
The affected product is identified by Lot #18J1081 with an expiration date of 03/10/19. Prescriptions for this product were filled for patients in Alaska, Arizona, California, Colorado, the District of Columbia, Florida, Indiana, Massachusetts, Montana, North Carolina, New Jersey, New York, Oregon, South Carolina, Texas, Utah, Virginia, Washington, and Wisconsin.
Patients who have received this medication should contact their healthcare provider for further instructions. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recalled product
- Product
- Dimercaptopropanesulfonate Sodium (DMPS), Aqueous injection solution, 50mg/mL 5 mL SDV, Rx only, McGuff Compounding Pharmacy Services, Inc. Santa Ana, CA 92704
- Manufacturer
- McGuff Compounding Pharmacy Services, Inc.
- Category
- Drug — Injectable Medication
- Hazard
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 (2)
- Lot #18J1081
- Exp 03/10/19
Distribution
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