Class II · Moderate risk
Alyacen 7/7/7
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Epel 18 mg Estradiol Pellet
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Non-Sterility: The recalled lot failed sterility testing.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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
Drug: Estradiol
- Recalling firm
- Physician Preferred Medical, LLC
- Origin
- OK, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0982-2015 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Estradiol recalls
See all
Class II · Moderate risk
Estradiol Gel
Defective Container; packets were found to be either empty or partially full.
Class II · Moderate risk
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
Other sterility / contamination recalls from 2014
All sterility / contamination recalls
Class II · Moderate risk
Virazole (Ribavirin for Inhalation Solution, USP)
Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.
Class II · Moderate risk
Total parenteral nutrition various strengths
Lack of sterility assurance.
Class II · Moderate risk
L-cysteine various strengths
Lack of sterility assurance.
Class II · Moderate risk
Immune globulin g human various strengths
Lack of sterility assurance.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.