Partell Specialty Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns
Partell Specialty Pharmacy is recalling Testosterone 55 mg pellets in Nevada because they were sterilized using a non-approved 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, and the rubric specifies that FDA Class II recalls with hospitalization reports or significant injury/property-damage reports are Severe. While specific injury reports are not detailed in the text, the lack of assurance of sterility for a drug product is a significant safety hazard.
Plain-English summary
Partell Specialty Pharmacy is recalling Testosterone 55 mg pellets packaged in amber vials. The recall is being conducted because the firm used a non-approved method of sterilization for these drug products.
The affected products are prescription-only and were distributed only in Nevada. The specific lots involved are 20171024@53 with a best-use date of 04/22/2018, and 20180219@91 with a best-use date of 08/18/2018.
Consumers who have these specific lots of Testosterone pellets should stop using them and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- Testosterone 55 mg pellet packaged 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 — Testosterone Pellets
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 (4)
- Lot#: 20171024@53
- BUD 04/22/2018
- 20180219@91
- BUD 08/18/2018.
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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