Tri-Coast Pharmacy Recalls Testosterone Vials Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 882 vials of compounded testosterone products 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 and involves a lack of assurance of sterility in a drug product, which presents a significant risk of serious health consequences such as infection.
Plain-English summary
Tri-Coast Pharmacy is recalling 882 vials of Testosterone Cypionate/Enanthate/Propionate, 160 mg/20 mg/20 mg/mL (5 mL). The recall is being conducted because of a lack of assurance of sterility in the compounded products.
The affected products were compounded between May 17, 2016, and November 17, 2016. The recall includes specific lot codes with expiration dates ranging from November 9, 2016, to April 1, 2017. The products were distributed nationwide.
Consumers and healthcare providers should check their inventory for these specific lot codes and stop using the affected vials. Those who have questions about the recall should contact Tri-Coast Pharmacy.
The recalled product
- Product
- Testosterone Cypionate/Enanthate/Propionate, 160 mg/20 mg/20 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- Affected units
- 882
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)
- 07222016B (01/18/2017)
- 09012016A (02/28/2017)
- 06012016C (11/09/2016)
- 08042016E (01/31/2017)
- 10032016A (04/01/2017).
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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