Park Compounding Recalls Sterile Injection Solutions Due to Sterility Concerns
Park Compounding is recalling Methylcobalamin, Multitrace-5, and Testosterone Cypionate injections due to lack of sterility assurance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (injection) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrate, and Testosterone Cypionate (sesame oil) for injection. The recall is being conducted due to a lack of assurance of sterility for these products.
The affected products are sterile solutions intended for injection. The recall notice does not specify the number of units affected, the specific distribution locations, or the lot numbers involved. The source text does not report any illnesses or injuries associated with the use of these products.
Consumers and healthcare providers should stop using these products and contact their healthcare provider or the manufacturer for further instructions on how to return or dispose of the recalled items.
The recalled product
- Product
- Multitrace-5 Concentrate (Trace Elements -5 Conc Injection) Solution, Sterile 10mL Multiple Dose Vial, For Slow IV Administration After Dilution Only, Park Compounding, Irvine, CA
- Manufacturer
- South Coast Specialty Compounding, Inc.
- Category
- Drug — Injectable Solution
- Hazard
- Affected units
- 82
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 #05212013@20 and Lot#03212013@6
- Exp 11/17/2013
Distribution
Part of a larger recall action
This product is one of 3 recalled by South Coast Specialty Compounding, 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.
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