FDA Recalls Tri-Coast Pharmacy Testosterone Cypionate Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 1,244 vials of compounded Testosterone Cypionate in Sesame Oil nationwide due to a lack of assurance of sterility.
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 involves a risk of temporary or medically reversible adverse health consequences. The hazard of non-sterile injectable medication poses a significant risk of infection, aligning with the 'Severe' criteria for significant injury reports or high-risk contamination.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Testosterone Cypionate in Sesame Oil, 250 mg/mL, (5 ML) compounded by Tri-Coast Pharmacy. The recall involves 1,244 vials distributed nationwide. The specific reason for the recall is a lack of assurance of sterility.
The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. Known lot codes and expiration dates include 06272016A (12/24/2016), 08242016A (02/20/2017), 09212016B (03/20/2017), 07252016A (01/21/2017), 08112016B (02/07/2017), and 10252016L (02/28/2017).
Consumers and healthcare providers should check their inventory for these specific lot codes and dates. If you have this product, you should contact your healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Testosterone Cypionate in Sesame Oil, 250 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- Category
- Drug — Compounded Injectable
- Affected units
- 1,244
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 (5)
- 08242016A (02/20/2017)
- 09212016B (03/20/2017)
- 07252016A (01/21/2017)
- 08112016B (02/07/2017)
- 10252016L (02/28/2017).
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 80 recalled by Tri-Coast 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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