Testosterone Cypionate Injection Recalled for Lack of Sterility Assurance
First Pharma Associates is recalling Testosterone Cypionate 200 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 is classified as FDA Class II. The hazard is a lack of assurance of sterility, which poses a risk of harm (infection) but the source text does not report any illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
First Pharma Associates LLC dba Riverpoint Pharmacy is recalling Testosterone Cypionate 200 mg/mL Ethyl Oleate Injection, packaged in 7.2 mL, 9.6 mL, and 10.8 mL vials. The recall is being conducted due to a lack of assurance of sterility. The affected lots are 05032019@18, 05062019@20, and 05132019@1, with expiration dates of 08/04/2019, 08/06/2019, and 08/13/2019, respectively.
The recalled product was distributed only in Idaho and Washington. This is a prescription-only medication. The source text does not specify the number of units recalled or report any illnesses or injuries associated with the product.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Testosterone Cypionate 200 mg/mL Ethyl Oleate Injection, packaged in a) 7.2 mL. b) 9.6 mL, c) 10.8mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252.
- Category
- Drug — Injectable Steroid
- 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 (6)
- Lot #: a) 05032019@18
- Exp. 08/04/2019
- b) 05062019@20
- Exp. 08/06/2019
- c) 05132019@1
- Exp. 08/13/2019.
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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