Tri-Coast Pharmacy Recalls TriMix Injections Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 35 vials of TriMix compounded injections because the agency cannot assure the products are sterile.
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 hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of infection or serious injury.
Plain-English summary
Tri-Coast Pharmacy is recalling 35 vials of TriMix, a compounded injection containing Alprostadil, Phentolamine, and Papaverine. The recall is being conducted because there is a lack of assurance of sterility for the products.
The recall includes all sterile products compounded by Tri-Coast Pharmacy between May 17, 2016, and November 17, 2016. The distribution of these products was nationwide. Specific lot codes and expiration dates are listed in the official recall notice.
Consumers who have these products should stop using them and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- TriMix, Alprostadil/Phentolamine/Papaverine 10mcg/1mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- Category
- Drug — Compounded Injectable
- Affected units
- 35
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 (8)
- 07212016A (09/01/2016)
- 07292016B (09/08/2016)
- 08012016F (09/08/2016)
- 09072016C (09/27/2016)
- 11012016C (12/09/2016)
- 05182016E (07/02/2016)
- 09012016C (09/29/2016)
- 09272016H (11/06/2016).
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.
See all 80 products in this recall →Related recalls
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