The Recall Desk
HighFDA (Drugs)·D-0982-2016·Announced 2016-06-15

Well Care Compounding Pharmacy Recalls Estradiol Valerate Due to Sterility Concerns

Well Care Compounding Pharmacy is recalling Estradiol Valerate 10mg/mL vials because FDA inspections found GMP violations that may affect sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility issues) where injury has not yet been reported, which aligns with the 'High' severity criteria.

Plain-English summary

Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling Estradiol Valerate 10mg/mL, packaged in 1mL and 5mL vials. The recall involves 869 units distributed in Nevada.

The recall was initiated because FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product. The source text does not report any illnesses or injuries associated with these products.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.

The recalled product

Product
ESTRADIOL VALERATE 10MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Manufacturer
Well Care Compounding Pharmacy
Category
Drug — Compounded Prescription
Hazard
Affected units
869

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 (12)

  • Lot #: 02022016:85@22
  • Exp.05/03/2016
  • Lot #: 02242016:50@16
  • Exp. 06/12/2016
  • Lot #:03102016:30@65
  • Exp. 06/12/2016
  • Lot #: 3172016:14@19
  • Exp. 06/15/2016
  • Lot #: 04122016:20@2
  • Exp. 07/11/2016
  • Lot #: 04212016:84@1
  • Exp. 07/20/2016.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 51 recalled by Well Care Compounding Pharmacy 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 51 products in this recall →

Related recalls

Same manufacturer · Well Care Compounding Pharmacy

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Same hazard · sterility

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