Pallimed Solutions Recalls HCG Vials Due to Sterility Concerns
Pallimed Solutions is recalling 261 vials of compounded HCG Chorionic Gonadotropin nationwide due to FDA inspectional findings regarding 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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric. The hazard involves a lack of assurance of sterility, which poses a significant risk of infection or serious injury.
Plain-English summary
Pallimed Solutions Pharmacy in Woburn, Massachusetts, is recalling 261 vials of compounded HCG Chorionic Gonadotropin. The recall is being conducted nationwide for all lots within their expiry dates.
The FDA initiated this recall following inspectional findings that raised concerns about quality control procedures. Specifically, the inspection identified issues that impacted the assurance of sterility for the product.
Consumers who possess these vials should stop using them and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- HCG Chorionic Gonadotropin, compounded by Pallimed Solutions Pharmacy, Woburn, MA
- Manufacturer
- Pallimed Solutions
- Category
- Drug — Compounded Biologic
- Hazard
- Affected units
- 261
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.
See all 25 products in this recall →Related recalls
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