Pallimed Solutions Recalls Hydroxyprogesterone Compounded Due to Sterility Concerns
Pallimed Solutions is recalling compounded Hydroxyprogesterone CAPR. (G.S.) due to FDA inspectional findings regarding quality control and sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. 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. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant quality control failures like sterility assurance.
Plain-English summary
Pallimed Solutions Pharmacy in Woburn, Massachusetts, is recalling compounded Hydroxyprogesterone CAPR. (G.S.). The recall is being conducted because FDA inspectional findings raised concerns about quality control procedures that impacted the assurance of sterility for the product.
The recall covers all lots of the product within their expiration dates. The distribution pattern for the affected product is listed as nationwide.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Hydroxyprogesterone CAPR.(G.S.), compounded by Pallimed Solutions Pharmacy, Woburn MA
- Manufacturer
- Pallimed Solutions
- Category
- Drug — Compounded Medication
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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