Med Prep Consulting Recalls Compounded Products Due to Sterility Concerns
Med Prep Consulting, Inc. is recalling all compounded products due to a lack of assurance of sterility and potential mold contamination.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential mold contamination in compounded medical products, which poses a significant risk of serious injury.
Plain-English summary
Med Prep Consulting, Inc. is recalling all compounded products packaged in plastic infusion bags, devices, syringes, and glass vials. The recall is being conducted because of a lack of assurance of sterility and the potential for mold contamination.
The affected products were distributed to Delaware, Florida, Illinois, Indiana, Maine, Michigan, New Jersey, Pennsylvania, Texas, and Virginia. The recall covers all lots of the specified products.
Consumers who have these products should stop using them and contact Med Prep Consulting, Inc. for further instructions or a refund.
The recalled product
- Product
- All Compounded Products, packaged in plastic infusion bags, devices, syringes and glass vials, Med Prep Consulting Inc., Tinton Falls, NJ 07712
- Manufacturer
- Med Prep Consulting, Inc.
- Category
- Drug — Compounded Products
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 (1)
- All lots
Distribution
Part of a larger recall action
This product is one of 2 recalled by Med Prep Consulting, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Med Prep Consulting, Inc.
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