Estradiol Valerate Recall Due to Sterility Assurance Concerns
Well Care Compounding Pharmacy is recalling Estradiol Valerate 40mg/mL vials because FDA inspections found GMP violations that may affect sterility.
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, particularly given the potential impact on sterility of a medical product.
Plain-English summary
Well Care Compounding Pharmacy is recalling Estradiol Valerate 40mg/mL, packaged in 1mL and 5mL vials. The recall involves 869 units distributed in Nevada. The product is prescription-only.
The recall was initiated because FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. This lack of assurance of sterility is the primary reason for the recall.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the pharmacy for instructions on how to return or dispose of the medication.
The recalled product
- Product
- ESTRADIOL VALERATE 40MG/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 #: 02162016:85@45
- Exp. 5/17/2016
- Lot #:03092016:30@19
- Exp. 06/07/2016
- Lot #: 01282016:77@25
- Exp.05/03/2016
- Lot #: 3112016:98@21
- Exp. 06/13/2016
- Lot #:03242016:52@22
- Exp. 06/27/2016
- Lot #: 04122016:15@50
- Exp. 7/11/2016
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.
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