Partell Specialty Pharmacy Recalls Estradiol Pellets Due to Sterility Concerns
Partell Specialty Pharmacy is recalling Estradiol 35 mg pellets in Nevada due to the use of a non-approved sterilization method.
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 risk of infection from lack of sterility assurance.
Plain-English summary
Partell Specialty Pharmacy is recalling Estradiol 35 mg (SD) pellets in amber vials. The recall is being conducted because the firm used a non-approved method of sterilization for these drug products.
The affected product is prescription-only Estradiol 35 mg (SD) pellets. The specific lot number is #20171102@42, with a beyond-use date of 05/01/2018. The distribution was limited to Nevada.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- Estradiol 35 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
- Manufacturer
- Partell Specialty Pharmacy
- Category
- Drug — Sterile Injectable
- Hazard
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: #20171102@42
- BUD 05/01/2018.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 49 recalled by Partell Specialty 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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