Pallimed Solutions Recalls Testosterone Injection Due to Sterility Concerns
Pallimed Solutions is recalling Testosterone Cypionate/Propionate Injection nationwide because FDA inspectional findings raised concerns about quality control procedures that impacted sterility assurance.
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 source text identifies the agency classification as Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterility assurance issues which carry significant risk.
Plain-English summary
Pallimed Solutions Pharmacy in Woburn, Massachusetts, is recalling Testosterone Cypionate/Propionate Injection. The recall involves 10 vials distributed nationwide. The recall is being conducted because FDA inspectional findings resulted in concerns associated with quality control procedures that impacted the assurance of sterility for the product.
The source text does not specify a particular lot number, stating instead that all lots within expiry are affected. No specific dates of distribution or specific patient counts are provided in the notice.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Testosterone Cypionate/Propionate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
- Manufacturer
- Pallimed Solutions
- Category
- Drug — Injectable Steroid
- Affected units
- 10
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 within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 25 recalled by Pallimed Solutions 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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