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.
EstroGel (estradiol gel)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Defective Container: Pump head detaching from the canister unit upon removal of the overcap.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
EstroGel (estradiol gel) 0.06%, contained in 50-gr metered pumps, 1.25g/pump depression, for use as physician starter samples; product is labeled in part ***Manufactured for ASCEND Therapeutics Herndon, VA 20170 by DPT Laboratories San Antonio TX 78215***
Drug: Estradiol
- Recalling firm
- Ascend Therapeutics Inc
- Origin
- VA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-146-2013 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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 packaging defect recalls from 2012
All packaging defect recalls
Class III · Low risk
Flanax (aluminum hydroxide, magnesium hydroxide, and simethicone)
Defective Container: Product lacks tamper evident breakaway band on cap.
Class II · Moderate risk
Nutropin AQ NuSpin 10
Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and the injection took longer than usual (slow dose delivery).
Class II · Moderate risk
Nutropin AQ NuSpin 20
Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and the injection took longer than usual (slow dose delivery).
Class II · Moderate risk
Synthroid (levothyroxine sodium)
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
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