Testosterone Cypionate Injection Recalled for Lack of Sterility Assurance
First Pharma Associates is recalling Testosterone Cypionate 100 mg/mL injections due to a lack of assurance of sterility. The product was distributed in Idaho and Washington.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk hazard (lack of sterility assurance for an injectable drug) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
First Pharma Associates LLC dba Riverpoint Pharmacy is recalling Testosterone Cypionate 100 mg/mL Sesame Oil Injection, 12mL vials. The recall is being conducted because of a lack of assurance of sterility for the product.
The affected product is prescription-only and was distributed in Idaho and Washington. Specific lot numbers and expiration dates are listed in the recall documentation. The source text does not report any illnesses or injuries associated with this recall.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Testosterone Cypionate 100 mg/mL Sesame Oil Injection, 12mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
- Category
- Drug — 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 (4)
- Lot #: 04192019@1
- Exp. 07/21/2019
- 05312019@4
- Exp. 09/03/2019
Distribution
Part of a larger recall action
This product is one of 18 recalled by First Pharma Associates LLC dba Riverpoint 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.
See all 18 products in this recall →Related recalls
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- Severe