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.
What this means for you
Illness, injury, or structural failure has been reported. 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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