Physician Preferred Medical Recalls Epel 18 mg Estradiol Pellets Due to Sterility Failure
Physician Preferred Medical, LLC is recalling Epel 18 mg Estradiol Pellets because the specific lot failed sterility testing. The product was distributed in Arizona and Kansas.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which per the rubric mandates a score of 5 (Critical) regardless of other factors.
Plain-English summary
Physician Preferred Medical, LLC is recalling Epel 18 mg Estradiol Pellets, a prescription-only product intended for in-office administration. The recall involves 122 pellets from Lot # 06241401-070714Q, which has an expiration date of 12/14.
The recall was initiated because the recalled lot failed sterility testing. This indicates a potential non-sterility issue with the product.
The affected product was distributed in Arizona (AZ) and Kansas (KS). The product is labeled for in-office use only and is not for resale or dispensing to individual patients. Healthcare providers and patients who have used or possess this specific lot should contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Epel 18 mg Estradiol Pellet, For In Office Use Only, For In Office Administration Only, Not for Resale or Dispensing to an Individual Patient, Rx Only, Preferred Physician Medical LLC, 405-551-8216
- Manufacturer
- Physician Preferred Medical, LLC
- Category
- Drug — Prescription Pellet
- Hazard
- Affected units
- 122
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 # 06241401-070714Q
- Exp 12/14
Distribution
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