FDA Recalls Estradiol Cypionate Injectable Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling Estradiol Cypionate injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
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, and the hazard involves a lack of sterility assurance in an injectable product, which poses a significant risk of serious injury or infection.
Plain-English summary
The U.S. Food and Drug Administration has issued a recall for Estradiol Cypionate (Compounded/Grapeseed Oil), 5 mg/mL, injectable, 1 ml glass vials. The product is manufactured by Oregon Compounding Centers, Inc. dba Creative Compounds, located in Wilsonville, Oregon.
The recall was initiated due to a lack of sterility assurance. This action covers all lots of sterile products compounded by the pharmacy that are not expired. The decision follows concerns regarding quality control procedures that present a potential risk to sterility assurance, which were observed during a recent FDA inspection.
The affected product was distributed in Oregon and Washington. Consumers and healthcare providers should check their inventory for this specific product and lot number (20140828@15) with a discard date of 10/12/2014. If the product is found, it should be returned to the pharmacy or manufacturer for disposal or credit.
The recalled product
- Product
- ESTRADIOL CYPIONATE (COMPOUNDED/GRAPESEED OIL), 5 mg/mL, injectable, 1 ml glass vial, RX, Creative Compounds, Wilsonville, OR 97070
- Category
- Drug — Compounded Injectable
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 #: 20140828@15
- discard date: 10/12/2014
Distribution
Part of a larger recall action
This product is one of 56 recalled by Oregon Compounding Centers, Inc. dba Creative Compounds 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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